Bio-Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bio-Medical Devices, Inc.” (first 1994, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 139 days. 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 | 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 |
|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | 3 | 3 |
| FQH | Lavage, Jet | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Bio-Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040485 | MAXAIR SURGICAL HELMET SYSTEM | FYA | 2004-10-18 | 236 |
| K981888 | SMOKE-EVAC | GEI | 1998-10-15 | 139 |
| K955151 | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR | BYY | 1996-01-24 | 72 |
| K955149 | MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL | BYY | 1996-01-24 | 72 |
| K955150 | MAXI-FLOW | BYY | 1996-01-23 | 71 |
| K940156 | THE REEL THING | GBX | 1994-06-07 | 146 |
| K933742 | TOP GUN | FQH | 1994-04-07 | 247 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Medical Devices, Inc..
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 Bio-Medical Devices, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Bio-Medical Devices, Inc.” (first 1994, latest 2004), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bio-Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Medical Devices, Inc. is 139 days.
Which FDA product codes appear under Bio-Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are BYY (Tube, Aspirating, Flexible, Connecting, 3); FQH (Lavage, Jet, 1); FYA (Gown, Surgical, 1).
Next steps
- See all 7 Bio-Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYY, Bio-Medical Devices, 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.