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
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2014-11-04 | Z-0846-2015 | Class II | Terminated | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.Distribution: Worldwide Distribution. | 19,978 units total (9,792 units in US) | clearance family |
Regulatory clearances
- 510(k)K182404Substantially equivalent (SESE) · 2018-12-27clearance family
- 510(k)K111377Substantially equivalent (SESE) · 2012-09-13clearance family
Predicate lineage
- K182404
Cited as predicate by: K192025
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
None in the loaded window.
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