# K192762: Physio Flex Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 16, 2019 after 77 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: 2 generations back to K926138 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083470: Carpentier- Edwards Physio II Annuloplasty, Model 5200, Edwards Lifesciences, LLC (2009) Summary page 4.

## Indications for use
The Physio Flex Annuloplasty Ring, model 5300, is indicated for the correction of mitral valve insufficiency, or mixed mitral insufficiency, where treatment does not necessitate replacement of the natural mitral valve.

Source page: https://510kreport.com/device/K192762
Methodology: https://510kreport.com/methodology