# K912554: Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 9, 1991 after 90 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; 2 cite 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring (2011), 3 descendants of its own
- K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (2017), 1 descendant of its own
- K260498: TriMemo™ SEMIRIGID ANNULOPLASTY RING (2026), 0 descendants of its own
- K171431: HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (2017), 0 descendants of its own
- K083623: Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K912554
Methodology: https://510kreport.com/methodology