Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionVAPROX0724995MMVAPROXHCRFID2U
Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
3 linked reportsMalfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3 |
| 2019-02 | 0 | 2.83 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.4 |
| 2019-06 | 0 | 1.4 |
| 2019-07 | 0 | 3.67 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 2.4 |
| 2019-10 | 0 | 3.8 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 4.33 |
| 2020-01 | 0 | 2.17 |
| 2020-02 | 0 | 4 |
| 2020-03 | 0 | 1.71 |
| 2020-04 | 0 | 3.14 |
| 2020-05 | 0 | 1.8 |
| 2020-06 | 0 | 3 |
| 2020-07 | 0 | 2.29 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 2.5 |
| 2020-10 | 0 | 2.33 |
| 2020-11 | 0 | 2.5 |
| 2020-12 | 0 | 1.6 |
| 2021-01 | 0 | 2.33 |
| 2021-02 | 0 | 3.5 |
| 2021-03 | 0 | 2.43 |
| 2021-04 | 0 | 4.5 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 2.83 |
| 2021-08 | 0 | 2.08 |
| 2021-09 | 0 | 2.8 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 0 | 2.13 |
| 2021-12 | 0 | 2.57 |
| 2022-01 | 0 | 2.5 |
| 2022-02 | 0 | 1.17 |
| 2022-03 | 0 | 3 |
| 2022-04 | 0 | 2.4 |
| 2022-05 | 0 | 2.88 |
| 2022-06 | 0 | 1.83 |
| 2022-07 | 0 | 2.67 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.86 |
| 2022-10 | 0 | 1.63 |
| 2022-11 | 0 | 1.88 |
| 2022-12 | 0 | 3.17 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.73 |
| 2023-03 | 0 | 1.78 |
| 2023-04 | 0 | 2.5 |
| 2023-05 | 0 | 2.8 |
| 2023-06 | 0 | 1.92 |
| 2023-07 | 0 | 2.3 |
| 2023-08 | 0 | 2.4 |
| 2023-09 | 0 | 1.56 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 2.75 |
| 2024-01 | 0 | 1.33 |
| 2024-03 | 0 | 1.25 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1.5 |
| 2024-06 | 0 | 2 |
| 2024-08 | 0 | 3.67 |
| 2024-09 | 0 | 4.75 |
| 2024-10 | 0 | 2.5 |
| 2024-11 | 0 | 1.7 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 1.6 |
| 2025-02 | 0 | 1.67 |
| 2025-03 | 0 | 2 |
| 2025-04 | 3 | 2.75 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 0 | 4.6 |
| 2025-07 | 0 | 5 |
| 2025-08 | 0 | 3.33 |
| 2025-09 | 0 | 2.67 |
| 2025-10 | 0 | 2.33 |
| 2025-11 | 0 | 3 |
| 2025-12 | 0 | 1.71 |
| 2026-01 | 0 | 3.4 |
| 2026-02 | 0 | 5 |
| 2026-03 | 0 | 2.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 2.8 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-04-23 | 3003950207-2025-00005 | Malfunction | Available | catalog number |
Showing the most recent 1 of 3 linked reports.
Regulatory clearances
- 510(k)K233065Substantially equivalent (SESE) · 2023-10-20clearance family
- 510(k)K222093Substantially equivalent (SESE) · 2022-09-09clearance family
- 510(k)K190917Substantially equivalent (SESE) · 2019-05-09clearance family
- 510(k)K190103Substantially equivalent (SESE) · 2019-04-05clearance family
- 510(k)K182568Substantially equivalent (SESE) · 2019-01-03clearance family
- 510(k)K172754Substantially equivalent (SESE) · 2018-02-09clearance family
Predicate lineage
- K172754
Cited as predicate by: K172755
- K182568
- K190917
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-04-16 | NAI | No action indicated | Steris Corporation | 0 |
| 2026-04-16 | NAI | No action indicated | Steris Corporation | 0 |
| 2026-04-03 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2026-03-12 | NAI | No action indicated | Isomedix Operations Inc | 0 |
| 2026-02-26 | VAI | Voluntary action indicated | Steris S.p.A. | 1 |
| 2026-02-12 | VAI | Voluntary action indicated | Synergy Health Ede BV | 2 |
| 2026-02-12 | NAI | No action indicated | Synergy Health Marseille | 0 |
| 2025-12-12 | OAI | Official action indicated | Black Diamond Video Inc. | 3 |
| 2025-08-01 | VAI | Voluntary action indicated | STERIS Laboratories, Inc. | 2 |
| 2025-06-18 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2025-06-17 | NAI | No action indicated | Isomedix Operations Inc | 0 |
| 2025-06-05 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2025-04-01 | NAI | No action indicated | Steris Corporation | 0 |
| 2025-02-21 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2025-01-23 | NAI | No action indicated | Synergy Health Allershausen GmbH | 0 |
| 2024-12-12 | VAI | Voluntary action indicated | Isomedix Operations, Inc | 0 |
| 2024-12-05 | NAI | No action indicated | Steris (Synergy Health Ede BV) | 0 |
| 2024-11-21 | VAI | Voluntary action indicated | Steris Applied Sterilization Technologies ULC | 2 |
| 2024-09-23 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2024-09-19 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2015-02-20 | WL | Warning Letter | Key Surgical LLC | — |
| 2014-05-22 | WL | Warning Letter | Isomedix Operations, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Albert Browne Ltd. | — |
| 2011-02-09 | WL | Warning Letter | Steris Corporation | — |
| 2011-02-09 | WL | Warning Letter | Steris Corporation | — |
| 2010-09-27 | WL | Warning Letter | Isomedix Operations, Inc. | — |
| 2010-04-20 | INJ | Injunction | Steris Corporation | — |
| 2010-04-20 | INJ | Injunction | Steris Corporation | — |
| 2009-07-31 | WL | Warning Letter | Medivators Inc | — |
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