FDA product code OVY: Liquid Chemical Processing System
OVY is the FDA product code for liquid chemical processing system. It is a Class II device, regulated under 21 CFR 880.6887 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under OVY, 2 in the last five years. The average 510(k) review took 69 days (median 88). 1 De Novo request was granted under it.
Definition
The liquid chemical processing system is intended as a standard method for routine monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Liquid Chemical Processing System |
| Device class | Class II |
| Regulation | 21 CFR 880.6887 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for OVY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 89 |
| 2023 | 2 | 58 |
Top OVY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 3 | 2023-12-15 |
Most recent OVY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233682 | STERIS Corporation | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | 2023-12-15 | 29 |
| K231746 | STERIS Corporation | VERIFY Spore Test Strip for S40 Sterilant Concentrate | 2023-09-11 | 88 |
| K180553 | STERIS Corporation | VERIFY Spore Test Strip for S40 Sterilant | 2018-05-29 | 89 |
Recalls for OVY devices
openFDA lists no recalls for product code OVY.
Frequently asked questions
What is FDA product code OVY?
OVY is the FDA product code for liquid chemical processing system. It is a Class II device, regulated under 21 CFR 880.6887 and reviewed by the General Hospital panel.
What device class is OVY?
Class II, regulation 21 CFR 880.6887. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVY?
Across 3 cleared submissions the average was 69 days from receipt to decision (median 88).
Which companies have the most OVY clearances?
STERIS Corporation (3).
Next steps
- Run an FDA pathway report with predicate devices for product code OVY
- Run a recall and safety report across every OVY manufacturer
- Watch product code OVY 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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