# Genesee Biomedical, Inc.

- Location (FDA's records): Denver, CO
- FDA decisions: 14 (2005–2026): 14 510(k) clearances
- Product codes: KRH (13), PZX (1)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pioneering Technologies, Inc.: 4 (https://510kreport.com/company/pioneering-technologies)
- Shiley, Inc.: 1 (https://510kreport.com/company/shiley)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)
- Syntheon, LLC: 1 (https://510kreport.com/company/syntheon)

## Firms that cite its devices most
- Medtronic, Inc.: 3 (https://510kreport.com/company/medtronic)

## Its most-cited devices
- K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR (2007), cited by 3
- K052565: Ats Simulus Annuloplasty Ring, Model 700FF (2005), cited by 2
- K052899: Ats Simulus Annuloplasty Band, Model 700FC (2005), cited by 1
- K093903: Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC (2010), cited by 1
- K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF) (2024), cited by 1
- K190506: NeoForm Annuloplasty Ring (2019), cited by 1

## Recent decisions
- K252917: ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (May 22, 2026)
- K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF) (Jul 25, 2025)
- K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF) (Apr 9, 2024)
- K230679: WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
- K202253: TruForm Sievers Annuloplasty Ring (Oct 6, 2020)
- K190506: NeoForm Annuloplasty Ring (Apr 18, 2019)
- K161815: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band (Oct 12, 2016)
- K093903: Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC (Jul 15, 2010)

Source page: https://510kreport.com/company/genesee-biomedical