Bionomy, Inc.: FDA clearances and approvals
Bionomy, Inc. has 5 FDA 510(k) clearances (first 1981, latest 1985), across 4 product codes in 3 review panels. Median 510(k) review time: 53 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYG | Catheter, Flow Directed | 2 | 2 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
Review panels
Most recent Bionomy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851101 | BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET | FOZ | 1985-04-12 | 24 |
| K844094 | PRUITT IRRIGATION AND OCCLUSION CATHETER | GBX | 1984-11-29 | 42 |
| K832023 | EMBOLECTOMY CATHETER | DXE | 1983-08-31 | 79 |
| K812111 | PRUITT ARTERIAL OCCLUSION CHOLANG. CATH | DYG | 1981-11-16 | 112 |
| K811276 | OCCLUSION CATHETER | DYG | 1981-06-30 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Bionomy, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bionomy, Inc. have?
Bionomy, Inc. has 5 FDA 510(k) clearances (first 1981, latest 1985), across 4 product codes in 3 review panels.
How long does FDA take to clear Bionomy, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bionomy, Inc.'s cleared 510(k)s is 53 days.
What devices does Bionomy, Inc. make?
Its most frequent FDA product codes are DYG (Catheter, Flow Directed, 2); DXE (Catheter, Embolectomy, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Has Bionomy, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bionomy, Inc. Related entities may recall under other names.
Next steps
- See all 5 Bionomy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYG, Bionomy, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.