# K970375: Annuloflo System

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Jul 25, 1997 after 172 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Carpentier-Edwards Classic™ Annuloplasty Ring: named in the summary without a submission number

## Most influential descendants
- K071327: Memo 3D Semirigid Annuloplasty Ring (2007), 4 descendants of its own
- K142221: MEMO 3D ReChord (2014), 3 descendants of its own
- K180411: MEMO 4D (2018), 2 descendants of its own
- K230318: Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (2023), 1 descendant of its own
- K261707: MEMO 4D Curve™ Semirigid mitral annuloplasty ring (2026), 0 descendants of its own

## Indications for use
The AnnuloFlo™ 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/K970375
Methodology: https://510kreport.com/methodology