# K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF)

- Pathway: 510(k) (Traditional)
- Applicant: Genesee Biomedical, Inc.
- Decided: Jul 25, 2025 after 126 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: 3 generations back to K905175 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF), Genesee Biomedical, Inc. (2024) Summary page 5.

## Indications for use
TransForm™ McCarthy Mitral Annuloplasty Ring (TF) 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/K250859
Methodology: https://510kreport.com/methodology