# K251982: Edwards MC3 Tricuspid annuloplasty ring (4900)

- Pathway: 510(k) (Abbreviated)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 23, 2025 after 88 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 K923367 (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)
- K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900, Edwards Lifesciences, LLC (2002) Summary page 5.

## Indications for use
The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

Source page: https://510kreport.com/device/K251982
Methodology: https://510kreport.com/methodology