FDA product code OWP: Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
OWP is the FDA product code for biological sterilization process indicator with recombinant-dna plasmid. It is a Class II device, regulated under 21 CFR 880.2805 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under OWP. The average 510(k) review took 118 days (median 136). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Biological Sterilization Process Indicator With Recombinant-Dna Plasmid |
| Device class | Class II |
| Regulation | 21 CFR 880.2805 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for OWP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 153 |
| 2018 | 1 | 12 |
Compare with all 510(k) review times · Search every OWP clearance
Top OWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 4 | 2018-06-13 |
Most recent OWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181442 | STERIS Corporation | VERIFY Assert Self-Contained Biological Indicator | 2018-06-13 | 12 |
| K162945 | STERIS Corporation | VERIFY ASSERT STEAM Process Challenge Device | 2017-04-28 | 189 |
| K162701 | STERIS Corporation | VERIFY Assert Self-Contained Biological Indicator | 2017-03-24 | 177 |
| K163587 | STERIS Corporation | VERIFY Incubator for Assert Self Contained Biological Indicators | 2017-03-24 | 94 |
Recalls for OWP devices
openFDA lists no recalls for product code OWP.
Frequently asked questions
What is FDA product code OWP?
OWP is the FDA product code for biological sterilization process indicator with recombinant-dna plasmid. It is a Class II device, regulated under 21 CFR 880.2805 and reviewed by the General Hospital panel.
What device class is OWP?
Class II, regulation 21 CFR 880.2805. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWP?
Across 4 cleared submissions the average was 118 days from receipt to decision (median 136).
Which companies have the most OWP clearances?
STERIS Corporation (4).
Next steps
- Run an FDA pathway report with predicate devices for product code OWP
- Run a recall and safety report across every OWP manufacturer
- Watch product code OWP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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