OWP
5 FDA 510(k) clearances · Product code
177 daysmedian time to decision
675 days90th percentile
5clearances measured
FDA profile
- Official device name
- Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2805
- Medical specialty
- General Hospital
- FDA definition
- A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VERIFY Assert Self-Contained Biological Indicator (K181442) | STERIS Corporation | 2018-06-13 |
| VERIFY ASSERT STEAM Process Challenge Device (K162945) | STERIS Corporation | 2017-04-28 |
| VERIFY Assert Self-Contained Biological Indicator (K162701) | STERIS Corporation | 2017-03-24 |
| VERIFY Incubator for Assert Self Contained Biological Indicators (K163587) | STERIS Corporation | 2017-03-24 |
| VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR (DEN110006) | STERIS Corporation | 2013-07-12 |
Track OWP automatically
Every clearance here is in the API, with alerts when new ones post.