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VAPROX

Model PB012 · STERIS CORPORATION · DI 00724995153106

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

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (3)

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: 3

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: 0 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: 0 reports for this device; peer average 1.25/device2025-01: 0 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: 3 reports for this device; peer average 2.75/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 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: 0 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
2024-0301.25
2024-0401
2024-0501.5
2024-0602
2024-0803.67
2024-0904.75
2024-1002.5
2024-1101.7
2024-1201.25
2025-0101.6
2025-0201.67
2025-0302
2025-0432.75
2025-0501.75
2025-0604.6
2025-0705
2025-0803.33
2025-0902.67
2025-1002.33
2025-1103
2025-1201.71
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)
  • 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)

Predicate lineage

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

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