# K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF)

- Pathway: 510(k) (Traditional)
- Applicant: Genesee Biomedical, Inc.
- Decided: Apr 9, 2024 after 225 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 K905175 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161815: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band, Genesee Biomedical, Inc. (2016) Summary page 4.
- K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR, Genesee Biomedical, Inc. (2007) Summary page 4.

## Most influential descendants
- K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF) (2025), 0 descendants of its own

## Indications for use
TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.

Source page: https://510kreport.com/device/K232599
Methodology: https://510kreport.com/methodology