# KRH: Ring, Annuloplasty

- Device class: 2; regulation: 21 CFR 870.3800; FDA's rule: 510(k) required
- FDA decisions: 75
- 510(k) review time 2021–2025: median 88 days (middle half 67–117)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 2
- 2014: 1
- 2016: 1
- 2018: 2
- 2019: 2
- 2020: 2
- 2023: 2
- 2024: 1
- 2025: 4
- 2026: 2

## Most-cited predicates
- K926138: Carpentier-Edwards Physio Annuloplasty Ring (1993), cited by 7
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600 (1993), cited by 6
- K905175: Pti Annuloplasty Ring (Sterile) (1992), cited by 5
- K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900 (2002), cited by 4
- K032250: Geoform Annuloplasty Ring, Mitral Model 4200 (2003), cited by 3
- K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR (2007), cited by 3
- K071327: Memo 3D Semirigid Annuloplasty Ring (2007), cited by 2
- K831949: Prosthetic Rings #4400 Mitral & 4500 (1983), cited by 2
- K032810: Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore (2003), cited by 2
- K052565: Ats Simulus Annuloplasty Ring, Model 700FF (2005), cited by 2

Source page: https://510kreport.com/product-code/KRH
Data by year (CSV): https://510kreport.com/product-code/KRH.csv