# K202253: TruForm Sievers Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Genesee Biomedical, Inc.
- Decided: Oct 6, 2020 after 57 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 K190506 (2019). 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)
- K190506: NeoForm Annuloplasty Ring, Genesee Biomedical, Inc. (2019) Summary page 4.

## Indications for use
The TruForm Sievers Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.

Source page: https://510kreport.com/device/K202253
Methodology: https://510kreport.com/methodology