# K251688: Carpentier-Edwards Physio Annuloplasty Ring (4450)

- Pathway: 510(k) (Abbreviated)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 17, 2025 after 107 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926138 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926138: Carpentier-Edwards Physio Annuloplasty Ring, Baxter Healthcare Corp (1993) Summary page 5.

## Indications for use
The Carpentier-Edwards Physio annuloplasty ring is intended for the correction of mitral valve insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.

Source page: https://510kreport.com/device/K251688
Methodology: https://510kreport.com/methodology