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AMSCO V-PRO

Model V-PRO maX · Steris Mexico, S. de R.L. de C.V. · DI 00724995206987

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 (2)

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

Adverse-event reports — MAUDE (32)

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: 32

23562019-01: 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: 3 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: 1 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: 2 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: 3 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: 1 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: 4 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: 3 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: 0 reports for this device; peer average 2.75/device2025-05: 3 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: 6 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: 3 reports for this device; peer average 3/device2025-12: 3 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
2021-0832.08
2021-0902.8
2021-1002.13
2021-1112.13
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
2023-0221.73
2023-0301.78
2023-0402.5
2023-0502.8
2023-0631.92
2023-0702.3
2023-0802.4
2023-0911.56
2023-1101.5
2023-1202.75
2024-0101.33
2024-0301.25
2024-0401
2024-0501.5
2024-0642
2024-0803.67
2024-0904.75
2024-1002.5
2024-1131.7
2024-1201.25
2025-0101.6
2025-0201.67
2025-0302
2025-0402.75
2025-0531.75
2025-0604.6
2025-0705
2025-0863.33
2025-0902.67
2025-1002.33
2025-1133
2025-1231.71
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

  • K190103 SESE 2019-04-05 (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)
  • 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)
  • K102330 SESE 2011-08-12 (k number procode)

Predicate lineage

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

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

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

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

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

Manufacturer compliance record — Steris Mexico, S. de R.L. de C.V.

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