# K190506: NeoForm Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Genesee Biomedical, Inc.
- Decided: Apr 18, 2019 after 48 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K202253: TruForm Sievers Annuloplasty Ring (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K190506
Methodology: https://510kreport.com/methodology