# K052899: Ats Simulus Annuloplasty Band, Model 700FC

- Pathway: 510(k) (Special)
- Applicant: Genesee Biomedical, Inc.
- Decided: Nov 17, 2005 after 34 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
Longest line of descent: 1 generation back to K905175 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K905175: Pti Annuloplasty Ring (Sterile), Pioneering Technologies, Inc. (1992) Summary page 1.

## Most influential descendants
- K201449: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (2020), 0 descendants of its own

## Indications for use
The Genesee BioMedical ATS SIMULUS 700FC Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Source page: https://510kreport.com/device/K052899
Methodology: https://510kreport.com/methodology