Invo Bioscience: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Invo Bioscience” (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 269 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 269 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Invo Bioscience took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 269 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OYO | Culture, Intravaginal, Assisted Reproduction | 2 | 1 |
Review panels
Most recent Invo Bioscience 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222932 | INVOcell Intravaginal Culture System | OYO | 2023-06-22 | 269 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150008 | De Novo | Culture, Intravaginal, Assisted Reproduction | 2015-11-02 |
Recalls
openFDA lists no recalls under a recalling firm named Invo Bioscience.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Invo Bioscience is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04644380: Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation (Completed, started 2020-12-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invo Bioscience?
FDA lists 1 510(k) clearance under the applicant name “Invo Bioscience” (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Invo Bioscience?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invo Bioscience is 269 days.
Which FDA product codes appear under Invo Bioscience?
The most frequent FDA product codes under this applicant name are OYO (Culture, Intravaginal, Assisted Reproduction, 2).
Next steps
- See all 1 Invo Bioscience clearances with predicates and recalls
- Run predicate analysis for product code OYO, Invo Bioscience's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.