Keri Medical SA: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Keri Medical SA” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 449 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 |
|---|---|---|
| 2022 | 1 | 449 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Keri Medical SA took a median 449 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 441 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KYJ | Prosthesis, Finger, Constrained, Polymer | 1 | 1 |
| SFA | Prosthesis, Finger, Semi-Constrained, Metal/Polymer | 1 | 0 |
Review panels
- Orthopedic (2)
Most recent Keri Medical SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | KYJ | 2022-07-27 | 449 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240020 | PMA | TOUCH® CMC 1 Prosthesis | 2025-07-10 |
Recalls
openFDA lists no recalls under a recalling firm named Keri Medical SA.
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 Keri Medical SA is the lead sponsor of 3 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06546345: Post Market Clinical Follow-Up KeriFlex® (Recruiting, started 2023-11-14)
- NCT06546332: Post Market Clinical Follow-Up KeriFuse® (Active not recruiting, started 2022-07-05)
- NCT06546306: Post Market Clinical Follow-Up TOUCH® CMC 1 (Active not recruiting, started 2019-11-22)
Frequently asked questions
How many FDA 510(k) clearances are listed under Keri Medical SA?
FDA lists 1 510(k) clearance under the applicant name “Keri Medical SA” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes 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 Keri Medical SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keri Medical SA is 449 days.
Which FDA product codes appear under Keri Medical SA?
The most frequent FDA product codes under this applicant name are KYJ (Prosthesis, Finger, Constrained, Polymer, 1); SFA (Prosthesis, Finger, Semi-Constrained, Metal/Polymer, 1).
Next steps
- See all 1 Keri Medical SA clearances with predicates and recalls
- Run predicate analysis for product code KYJ, Keri Medical SA'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.