FDA product code OYO: Culture, Intravaginal, Assisted Reproduction
OYO is the FDA product code for culture, intravaginal, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6165 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under OYO, 1 in the last five years. The average 510(k) review took 269 days (median 269). 1 De Novo request was granted under it.
Definition
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Classification
| Field | Value |
|---|---|
| Device name | Culture, Intravaginal, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6165 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for OYO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 269 |
Compare with all 510(k) review times · Search every OYO clearance
Top OYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invo Bioscience | 1 | 2023-06-22 |
Most recent OYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222932 | Invo Bioscience | INVOcell Intravaginal Culture System | 2023-06-22 | 269 |
Recalls for OYO devices
openFDA lists no recalls for product code OYO.
Frequently asked questions
What is FDA product code OYO?
OYO is the FDA product code for culture, intravaginal, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6165 and reviewed by the Obstetrics and Gynecology panel.
What device class is OYO?
Class II, regulation 21 CFR 884.6165. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYO?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most OYO clearances?
Invo Bioscience (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OYO
- Run a recall and safety report across every OYO manufacturer
- Watch product code OYO 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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