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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K183300Substantially equivalent (SESE) · 2019-01-03clearance family
- 510(k)K172748Substantially equivalent (SESE) · 2018-02-09clearance family
- 510(k)K140499Substantially equivalent (SESE) · 2014-07-17clearance family
- 510(k)K103331Substantially equivalent (SESE) · 2011-09-01clearance family
Predicate lineage
- K172748
Cited as predicate by: K183300
- K183300
Cited as predicate by: K231490
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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