Genesee Biomedical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Genesee Biomedical, Inc.” (first 2005, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Since 2017 the median was 100 days, against 60 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 103 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 48 |
| 2020 | 1 | 57 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 74 |
| 2024 | 1 | 225 |
| 2025 | 1 | 126 |
| 2026 | 1 | 252 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Genesee Biomedical, Inc. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 60 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KRH | Ring, Annuloplasty | 13 | 13 |
| PZX | Left Atrial Appendage Clip, Implantable | 1 | 1 |
Review panels
- Cardiovascular (14)
Most recent Genesee Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | PZX | 2026-05-22 | 252 |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | 2025-07-25 | 126 |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | 2024-04-09 | 225 |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | KRH | 2023-05-26 | 74 |
| K202253 | TruForm Sievers Annuloplasty Ring | KRH | 2020-10-06 | 57 |
| K190506 | NeoForm Annuloplasty Ring | KRH | 2019-04-18 | 48 |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | KRH | 2016-10-12 | 103 |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | KRH | 2010-07-15 | 205 |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | KRH | 2009-05-07 | 77 |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | KRH | 2009-02-25 | 75 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-02-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Genesee Biomedical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Genesee Biomedical, Inc.” (first 2005, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genesee Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genesee Biomedical, Inc. is 76 days. Since 2017: 100 days, versus 60 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Genesee Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are KRH (Ring, Annuloplasty, 13); PZX (Left Atrial Appendage Clip, Implantable, 1).
Next steps
- See all 14 Genesee Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRH, Genesee Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.