# K992056: Annuloflex Annuloplasty System, Model AF800

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Carbomedics, Inc.
- Decided: Oct 12, 1999 after 116 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 its predicate without a number.
- (no number) Sulzer Carbomedics® AnnuloFlo - Annuloplasty Ring: named in the summary without a submission number
- (no number) Medtronic Duran Flexible Ring: named in the summary without a submission number
- (no number) Baxter Cosgrove-Edwards Ring: named in the summary without a submission number

## Most influential descendants
- K033685: Northrup Universal Annuloplasty System, Model 1000 (2004), 1 descendant of its own
- K071281: Uniring - Annuloplasty Ring with Sizers (2007), 0 descendants of its own

## Indications for use
The AnnuloFlex annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Source page: https://510kreport.com/device/K992056
Methodology: https://510kreport.com/methodology