510(k) Report

FDA applicant

Genesee Biomedical, Inc.

Denver, CO14 decisions2005–20260 recalls

FDA records 14 decisions for Genesee Biomedical, Inc. (Denver, CO) from 2005 to 2026: 14 510(k) clearances. Most are in product codes KRH (Ring, Annuloplasty) and PZX (Left Atrial Appendage Clip, Implantable). Its devices cite 14 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Genesee Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 22009: 22010: 12016: 12019: 12020: 12023: 12024: 12025: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genesee Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Genesee Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KRHRing, Annuloplasty13decisions
  • PZXLeft Atrial Appendage Clip, Implantable1decision

Whose devices does it build on?

Its devices cite 14 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072655Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRGenesee Biomedical, Inc. · 20073cite it
  • K052565Ats Simulus Annuloplasty Ring, Model 700FFGenesee Biomedical, Inc. · 20052cite it
  • K052899Ats Simulus Annuloplasty Band, Model 700FCGenesee Biomedical, Inc. · 20051cites it
  • K093903Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 20101cites it
  • K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 20241cites it
  • K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. · 20191cites it

What has FDA decided for it lately?

  • K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc. · 2026
  • K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2025
  • K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. · 2024
  • K230679WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc. · 2023
  • K202253TruForm Sievers Annuloplasty RingGenesee Biomedical, Inc. · 2020
  • K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. · 2019
  • K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc. · 2016
  • K093903Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCGenesee Biomedical, Inc. · 2010

All 14 as Genesee Biomedical, Inc. →