FDA product code KRH: Ring, Annuloplasty
KRH is the FDA product code for ring, annuloplasty. It is a Class II device, regulated under 21 CFR 870.3800 and reviewed by the Cardiovascular panel. FDA has cleared 75 510(k) submissions under KRH, 9 in the last five years, from 30 different applicants. The average 510(k) review took 102 days (median 77); 119 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Ring, Annuloplasty |
| Device class | Class II |
| Regulation | 21 CFR 870.3800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KRH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 29 |
| 2019 | 2 | 62 |
| 2020 | 2 | 44 |
| 2023 | 2 | 67 |
| 2024 | 1 | 225 |
| 2025 | 4 | 88 |
| 2026 | 2 | 44 |
Compare with all 510(k) review times · Search every KRH clearance
Top KRH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Genesee Biomedical, Inc. | 13 | 2025-07-25 |
| Edwards Lifesciences, LLC | 9 | 2025-09-23 |
| St. Jude Medical, Inc. | 7 | 2004-12-17 |
| Baxter Healthcare Corp | 4 | 1993-06-22 |
| Corcym S.r.l. | 3 | 2026-06-18 |
25 more applicants have KRH clearances. See the full list in Caduvo.
Most recent KRH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261707 | Corcym S.r.l. | MEMO 4D Curve Semirigid mitral annuloplasty ring | 2026-06-18 | 27 |
| K260498 | Corcym S.r.l. | TriMemo SEMIRIGID ANNULOPLASTY RING | 2026-04-14 | 60 |
| K253232 | ABBOTT MEDICAL | Seguin Annuloplasty Ring | 2025-10-29 | 30 |
| K251982 | Edwards Lifesciences, LLC | Edwards MC3 Tricuspid annuloplasty ring (4900) | 2025-09-23 | 88 |
| K251688 | Edwards Lifesciences, LLC | Carpentier-Edwards Physio Annuloplasty Ring (4450) | 2025-09-17 | 107 |
Recalls for KRH devices
openFDA lists no recalls for product code KRH.
Frequently asked questions
What is FDA product code KRH?
KRH is the FDA product code for ring, annuloplasty. It is a Class II device, regulated under 21 CFR 870.3800 and reviewed by the Cardiovascular panel.
What device class is KRH?
Class II, regulation 21 CFR 870.3800. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRH?
Across 75 cleared submissions the average was 102 days from receipt to decision (median 77).
Which companies have the most KRH clearances?
Genesee Biomedical, Inc. (13); Edwards Lifesciences, LLC (9); St. Jude Medical, Inc. (7); Baxter Healthcare Corp (4); Corcym S.r.l. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code KRH
- Run a recall and safety report across every KRH manufacturer
- Watch product code KRH 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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