# K926138: Carpentier-Edwards Physio Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 22, 1993 after 197 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.
12 later devices descend from it; 7 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K083470: Carpentier- Edwards Physio II Annuloplasty, Model 5200 (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K926138
Methodology: https://510kreport.com/methodology