Corcym S.r.l.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Corcym S.r.l.” (first 2023, latest 2026), plus 2 PMA decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 60 days, against 60 days for all cleared 510(k)s in the same product codes. 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 | 60 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 44 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Corcym S.r.l. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 60 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KRH | Ring, Annuloplasty | 3 | 3 |
| LWQ | Heart-Valve, Mechanical | 1 | 0 |
| LWR | Heart-Valve, Non-Allograft Tissue | 1 | 0 |
Review panels
- Cardiovascular (5)
Most recent Corcym S.r.l. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ring | KRH | 2026-06-18 | 27 |
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RING | KRH | 2026-04-14 | 60 |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | KRH | 2023-04-07 | 60 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150011 | PMA | PERCEVAL SUTURELESS HEART VALVE | 2016-01-08 |
| P900060 | PMA | CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) | 1993-09-29 |
Recalls
openFDA lists no recalls under a recalling firm named Corcym S.r.l..
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 Corcym S.r.l. is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05002543: CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting (Recruiting, started 2021-06-29)
- NCT03200574: Behavior of Valve Leaflets Following Aortic Valve Implant (Completed, started 2017-12-06)
- NCT00876525: Clinical Investigation of the Freedom SOLO Stentless Heart Valve (Completed, started 2009-03)
- NCT00860730: PERCEVAL Pivotal Trial (Completed, started 2009-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Corcym Canada Corp (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Corcym S.r.l.?
FDA lists 3 510(k) clearances under the applicant name “Corcym S.r.l.” (first 2023, latest 2026), plus 2 PMA decisions, across 3 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 Corcym S.r.l.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corcym S.r.l. is 60 days. Since 2017: 60 days, versus 60 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Corcym S.r.l.?
The most frequent FDA product codes under this applicant name are KRH (Ring, Annuloplasty, 3); LWQ (Heart-Valve, Mechanical, 1); LWR (Heart-Valve, Non-Allograft Tissue, 1).
Next steps
- See all 3 Corcym S.r.l. clearances with predicates and recalls
- Run predicate analysis for product code KRH, Corcym S.r.l.'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.