Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genesee Biomedical, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
225 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | 2026-05-22 | 252 | 0 |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2025-07-25 | 126 | 0 |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2024-04-09 | 225 | 0 |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | 2023-05-26 | 74 | 0 |
| K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | 2020-10-06 | 57 | 0 |
| K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | 2019-04-18 | 48 | 0 |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | 2016-10-12 | 103 | 0 |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SF | Genesee Biomedical, Inc. | 2010-07-15 | 205 | 0 |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | Genesee Biomedical, Inc. | 2009-05-07 | 77 | 0 |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | Genesee Biomedical, Inc. | 2009-02-25 | 75 | 0 |
| K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | Genesee Biomedical, Inc. | 2007-10-23 | 33 | 0 |
| K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | Genesee Biomedical, Inc. | 2007-07-31 | 91 | 0 |
| K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | Genesee Biomedical, Inc. | 2005-11-17 | 34 | 0 |
| K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | Genesee Biomedical, Inc. | 2005-11-17 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda