# K831949: Prosthetic Rings #4400 Mitral & 4500

- Pathway: 510(k) (Traditional)
- Applicant: American Edwards Laboratories
- Decided: Jul 29, 1983 after 43 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K032250: Geoform Annuloplasty Ring, Mitral Model 4200 (2003), 3 descendants of its own
- K083623: Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 (2009), 0 descendants of its own
- K083191: Detlogix Annuloplasty Ring, Model: 5100 (2009), 0 descendants of its own
- K042734: SJM Rigid Saddle Ring Model Rsar-(Size) (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K831949
Methodology: https://510kreport.com/methodology