FDA product code NKM: Mitral Valve Repair Devices
NKM is the FDA product code for mitral valve repair devices. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NKM reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 6 recalls for NKM devices, 4 initiated in the last five years.
Definition
To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
Classification
| Field | Value |
|---|---|
| Device name | Mitral Valve Repair Devices |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NKM devices
6 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-07-27.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code NKM?
NKM is the FDA product code for mitral valve repair devices. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NKM?
Class III. Typical premarket route: PMA.
Have NKM devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2023-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NKM
- Run a recall and safety report across every NKM manufacturer
- Watch product code NKM 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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