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VAPROX

Model PB007 · STERIS CORPORATION · DI 00724995089160

MLR — Sterilizer, Chemical · Class II · 21 CFR 880.6860

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (3)

InitiatedRecall #ClassStatusReasonLink basis
2018-07-26Z-2959-2018Class IITerminatedThere is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.k number procode
2017-09-28Z-0772-2018Class IITerminatedCorrection to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.k number procode
2011-08-01Z-3041-2011TerminatedSTERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device's chamber following a failed leak test.k number procode

Adverse-event reports — MAUDE (9)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 9

13452019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 2.83/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.4/device2019-06: 0 reports for this device; peer average 1.4/device2019-07: 0 reports for this device; peer average 3.67/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 2.4/device2019-10: 0 reports for this device; peer average 3.8/device2019-11: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 4.33/device2020-01: 0 reports for this device; peer average 2.17/device2020-02: 0 reports for this device; peer average 4/device2020-03: 0 reports for this device; peer average 1.71/device2020-04: 0 reports for this device; peer average 3.14/device2020-05: 0 reports for this device; peer average 1.8/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.29/device2020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 2.33/device2020-11: 0 reports for this device; peer average 2.5/device2020-12: 0 reports for this device; peer average 1.6/device2021-01: 0 reports for this device; peer average 2.33/device2021-02: 0 reports for this device; peer average 3.5/device2021-03: 0 reports for this device; peer average 2.43/device2021-04: 0 reports for this device; peer average 4.5/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.83/device2021-08: 0 reports for this device; peer average 2.08/device2021-09: 0 reports for this device; peer average 2.8/device2021-10: 0 reports for this device; peer average 2.13/device2021-11: 0 reports for this device; peer average 2.13/device2021-12: 0 reports for this device; peer average 2.57/device2022-01: 0 reports for this device; peer average 2.5/device2022-02: 0 reports for this device; peer average 1.17/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2.4/device2022-05: 0 reports for this device; peer average 2.88/device2022-06: 0 reports for this device; peer average 1.83/device2022-07: 0 reports for this device; peer average 2.67/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.86/device2022-10: 0 reports for this device; peer average 1.63/device2022-11: 0 reports for this device; peer average 1.88/device2022-12: 0 reports for this device; peer average 3.17/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1.73/device2023-03: 0 reports for this device; peer average 1.78/device2023-04: 0 reports for this device; peer average 2.5/device2023-05: 0 reports for this device; peer average 2.8/device2023-06: 0 reports for this device; peer average 1.92/device2023-07: 0 reports for this device; peer average 2.3/device2023-08: 0 reports for this device; peer average 2.4/device2023-09: 0 reports for this device; peer average 1.56/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 2.75/device2024-01: 0 reports for this device; peer average 1.33/device2024-03: 1 reports for this device; peer average 1.25/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 3.67/device2024-09: 0 reports for this device; peer average 4.75/device2024-10: 0 reports for this device; peer average 2.5/device2024-11: 0 reports for this device; peer average 1.7/device2024-12: 2 reports for this device; peer average 1.25/device2025-01: 2 reports for this device; peer average 1.6/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2.75/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 2 reports for this device; peer average 4.6/device2025-07: 0 reports for this device; peer average 5/device2025-08: 0 reports for this device; peer average 3.33/device2025-09: 0 reports for this device; peer average 2.67/device2025-10: 0 reports for this device; peer average 2.33/device2025-11: 0 reports for this device; peer average 3/device2025-12: 2 reports for this device; peer average 1.71/device2026-01: 0 reports for this device; peer average 3.4/device2026-02: 0 reports for this device; peer average 5/device2026-03: 0 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2.8/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809111201030405060809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0202.83
2019-0303
2019-0402
2019-0501.4
2019-0601.4
2019-0703.67
2019-0803
2019-0902.4
2019-1003.8
2019-1103
2019-1204.33
2020-0102.17
2020-0204
2020-0301.71
2020-0403.14
2020-0501.8
2020-0603
2020-0702.29
2020-0802
2020-0902.5
2020-1002.33
2020-1102.5
2020-1201.6
2021-0102.33
2021-0203.5
2021-0302.43
2021-0404.5
2021-0502
2021-0602
2021-0702.83
2021-0802.08
2021-0902.8
2021-1002.13
2021-1102.13
2021-1202.57
2022-0102.5
2022-0201.17
2022-0303
2022-0402.4
2022-0502.88
2022-0601.83
2022-0702.67
2022-0802
2022-0901.86
2022-1001.63
2022-1101.88
2022-1203.17
2023-0102
2023-0201.73
2023-0301.78
2023-0402.5
2023-0502.8
2023-0601.92
2023-0702.3
2023-0802.4
2023-0901.56
2023-1101.5
2023-1202.75
2024-0101.33
2024-0311.25
2024-0401
2024-0501.5
2024-0602
2024-0803.67
2024-0904.75
2024-1002.5
2024-1101.7
2024-1221.25
2025-0121.6
2025-0201.67
2025-0302
2025-0402.75
2025-0501.75
2025-0624.6
2025-0705
2025-0803.33
2025-0902.67
2025-1002.33
2025-1103
2025-1221.71
2026-0103.4
2026-0205
2026-0302.5
2026-0402
2026-0502
2026-0602.8
This device (reports/month)Average device in MLR (reports/device/month)

Regulatory clearances

  • K233065 SESE 2023-10-20 (k number procode)
  • K223476 SESE 2023-08-07 (k number procode)
  • K222093 SESE 2022-09-09 (k number procode)
  • K190917 SESE 2019-05-09 (k number procode)
  • K190103 SESE 2019-04-05 (k number procode)
  • K182568 SESE 2019-01-03 (k number procode)
  • K172754 SESE 2018-02-09 (k number procode)
  • K172319 SESE 2018-01-18 (k number procode)
  • K162413 SESE 2017-03-31 (k number procode)
  • K160433 SESE 2016-07-06 (k number procode)
  • K140498 SESE 2014-07-24 (k number procode)
  • K131120 SESE 2013-07-16 (k number procode)
  • K120632 SESE 2012-06-26 (k number procode)
  • K112813 SESE 2011-12-01 (k number procode)
  • K112760 SESE 2011-11-22 (k number procode)
  • K111810 SESE 2011-09-02 (k number procode)
  • K102394 SESE 2011-08-18 (k number procode)
  • K102330 SESE 2011-08-12 (k number procode)

Predicate lineage

K062297 — cited as predicate by K102330, K102394, K103226, K111810, K112760, K112813, K120632, K131120, K162413, K172319, K231893, K233065

K083097 — cited as predicate by K102330, K102394, K103226, K111810, K112760, K112813, K120632, K131120, K140464, K140498, K140499, K160433, K162413, K172319, K231893

K102330 — cites (transitively): K062297 (d1), K070765 (d1), K070769 (d1), K073244 (d1), K083097 (d1), K090636 (d1) — cited as predicate by K103226, K112760, K112813, K120632, K131120, K140498, K140499, K160433, K162413, K172319, K172749, K172754, K172755, K211895, K231893

K102394 — cites (transitively): K062297 (d1), K083097 (d1) — cited as predicate by K120632, K131120, K140498, K160433, K162413, K172319

K111810 — cites (transitively): K062297 (d1), K083097 (d1) — cited as predicate by K160433, K162413, K172319

K112760 — cites (transitively): K062297 (d1), K070765 (d1), K070769 (d1), K073244 (d1), K083097 (d1), K090371 (d1), K102330 (d1), K090636 (d2) — cited as predicate by K160433, K162413, K172319, K172754

K112813 — cites (transitively): K062297 (d1), K083097 (d1), K102330 (d1), K070765 (d2), K070769 (d2), K073244 (d2), K090636 (d2) — cited as predicate by K160433, K162413, K172319, K172754, K233065

K120632 — cites (transitively): K062297 (d1), K070769 (d1), K073244 (d1), K083097 (d1), K090371 (d1), K090514 (d1), K091174 (d1), K102330 (d1), K102394 (d1), K103226 (d1), K070765 (d2), K090636 (d2), K013003 (d2) — cited as predicate by K131120, K160433, K162413, K172319, K172754

K131120 — cites (transitively): K062297 (d1), K070769 (d1), K071087 (d1), K073244 (d1), K083097 (d1), K090371 (d1), K090514 (d1), K091174 (d1), K102330 (d1), K102394 (d1), K103226 (d1), K120632 (d1), K070765 (d2), K090636 (d2), K013003 (d2) — cited as predicate by K140498, K141163, K160433, K162413, K172319, K172749, K172754, K172755

K140498 — cites (transitively): K083097 (d1), K102330 (d1), K102394 (d1), K131120 (d1), K062297 (d2), K070765 (d2), K070769 (d2), K073244 (d2), K090636 (d2), K071087 (d2), K090371 (d2), K090514 (d2), K091174 (d2), K103226 (d2), K120632 (d2), K013003 (d3) — cited as predicate by K162413, K182568

K160433 — cites (transitively): K083097 (d1), K102330 (d1), K102394 (d1), K111810 (d1), K112760 (d1), K112813 (d1), K120632 (d1), K131120 (d1), K062297 (d2), K070765 (d2), K070769 (d2), K073244 (d2), K090636 (d2), K090371 (d2), K090514 (d2), K091174 (d2), K103226 (d2), K071087 (d2), K013003 (d3) — cited as predicate by K162413, K172319, K172749, K172755

K162413 — cites (transitively): K062297 (d1), K083097 (d1), K102330 (d1), K102394 (d1), K111810 (d1), K112760 (d1), K112813 (d1), K120632 (d1), K131120 (d1), K140498 (d1), K160433 (d1), K070765 (d2), K070769 (d2), K073244 (d2), K090636 (d2), K090371 (d2), K090514 (d2), K091174 (d2), K103226 (d2), K071087 (d2), K013003 (d3) — cited as predicate by K172319, K172754, K182568

K172319 — cites (transitively): K062297 (d1), K083097 (d1), K102330 (d1), K102394 (d1), K111810 (d1), K112760 (d1), K112813 (d1), K120632 (d1), K131120 (d1), K160433 (d1), K162413 (d1), K070765 (d2), K070769 (d2), K073244 (d2), K090636 (d2), K090371 (d2), K090514 (d2), K091174 (d2), K103226 (d2), K071087 (d2), K140498 (d2), K013003 (d3) — cited as predicate by K182568, K183297, K183301

K172754 — cites (transitively): K102330 (d1), K112760 (d1), K112813 (d1), K120632 (d1), K131120 (d1), K162413 (d1), K062297 (d2), K070765 (d2), K070769 (d2), K073244 (d2), K083097 (d2), K090636 (d2), K090371 (d2), K090514 (d2), K091174 (d2), K102394 (d2), K103226 (d2), K071087 (d2), K111810 (d2), K140498 (d2), K160433 (d2), K013003 (d3) — cited as predicate by K172755

K182568 — cites (transitively): K140498 (d1), K162413 (d1), K172319 (d1), K083097 (d2), K102330 (d2), K102394 (d2), K131120 (d2), K062297 (d2), K111810 (d2), K112760 (d2), K112813 (d2), K120632 (d2), K160433 (d2), K070765 (d3), K070769 (d3), K073244 (d3), K090636 (d3), K090371 (d3), K090514 (d3), K091174 (d3), K103226 (d3), K071087 (d3), K013003 (d4) — cited as predicate by K183300, K183301, K190027, K190917

K190103 — cited as predicate by K190027, K190917, K222093, K222543

K190917 — cites (transitively): K182568 (d1), K190103 (d1), K140498 (d2), K162413 (d2), K172319 (d2), K083097 (d3), K102330 (d3), K102394 (d3), K131120 (d3), K062297 (d3), K111810 (d3), K112760 (d3), K112813 (d3), K120632 (d3), K160433 (d3), K070765 (d4), K070769 (d4), K073244 (d4), K090636 (d4), K090371 (d4), K090514 (d4), K091174 (d4), K103226 (d4), K071087 (d4), K013003 (d5) — cited as predicate by K190027, K222543, K222849

K222093 — cites (transitively): K190103 (d1) — cited as predicate by K223476

K223476 — cites (transitively): K222093 (d1), K190103 (d2) — cited as predicate by K233065

K233065 — cites (transitively): K062297 (d1), K112813 (d1), K223476 (d1), K083097 (d2), K102330 (d2), K222093 (d2), K070765 (d3), K070769 (d3), K073244 (d3), K090636 (d3), K190103 (d3)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — STERIS CORPORATION

  • Warning Letter 2015-02-20 Key Surgical LLC
  • Warning Letter 2014-05-22 Isomedix Operations, Inc.
  • Warning Letter 2012-05-29 Albert Browne Ltd.
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2010-09-27 Isomedix Operations, Inc.
  • Injunction 2010-04-20 Steris Corporation
  • Injunction 2010-04-20 Steris Corporation
  • Warning Letter 2009-07-31 Medivators Inc
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-03 Isomedix Operations Inc. · 0 citations
  • NAI 2026-03-12 Isomedix Operations Inc · 0 citations
  • VAI 2026-02-26 Steris S.p.A. · 1 citations
  • VAI 2026-02-12 Synergy Health Ede BV · 2 citations
  • NAI 2026-02-12 Synergy Health Marseille · 0 citations
  • OAI 2025-12-12 Black Diamond Video Inc. · 3 citations
  • VAI 2025-08-01 STERIS Laboratories, Inc. · 2 citations
  • NAI 2025-06-18 Isomedix Operations Inc. · 0 citations
  • NAI 2025-06-17 Isomedix Operations Inc · 0 citations
  • NAI 2025-06-05 Isomedix Operations, Inc. · 0 citations
  • NAI 2025-04-01 Steris Corporation · 0 citations
  • NAI 2025-02-21 Isomedix Operations Inc. · 0 citations
  • NAI 2025-01-23 Synergy Health Allershausen GmbH · 0 citations
  • VAI 2024-12-12 Isomedix Operations, Inc · 0 citations
  • NAI 2024-12-05 Steris (Synergy Health Ede BV) · 0 citations
  • VAI 2024-11-21 Steris Applied Sterilization Technologies ULC · 2 citations
  • NAI 2024-09-23 Isomedix Operations, Inc. · 0 citations
  • NAI 2024-09-19 Isomedix Operations, Inc. · 0 citations