Bio-Med USA, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Bio-Med USA, Inc.” (first 2008, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 156 days. Since 2017 the median was 84 days, against 100 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 | 1 | 238 |
| 2013 | 1 | 156 |
| 2014 | 2 | 176 |
| 2015 | 1 | 212 |
| 2016 | 0 | — |
| 2017 | 1 | 143 |
| 2018 | 1 | 72 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 96 |
| 2022 | 1 | 49 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bio-Med USA, Inc. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| FMF | Syringe, Piston | 2 | 2 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
| ODR | Electrosurgical Patient Return Electrode | 1 | 1 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 1 | 1 |
Review panels
Most recent Bio-Med USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221789 | IRIS Pi Q switched Nd YAG laser | GEX | 2022-08-09 | 49 |
| K212082 | Picore | GEX | 2021-10-06 | 96 |
| K182270 | Cellene CO2 Laser System | GEX | 2018-11-02 | 72 |
| K163638 | Dental 5 Multi Diode laser | GEX | 2017-05-15 | 143 |
| K142332 | BT-400 | LBI | 2015-03-20 | 212 |
| K140837 | LUCID LY | GEX | 2014-09-24 | 175 |
| K133774 | ATOVEN | GEX | 2014-06-06 | 176 |
| K123710 | UNITOX BOTOX SYRINGE | FMF | 2013-05-09 | 156 |
| K121268 | WANDY DISPERSVIE ELECTRODE | ODR | 2012-12-20 | 238 |
| K111831 | MX-7000 MICROXEL | ONG | 2011-12-19 | 174 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio-Med USA, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bio-Med Devices, Inc. (14 510(k)s)
- Bio-Med Corp. (5 510(k)s)
- Bio-Med Device, Inc. (1 510(k)s)
- Bio-Med Systems Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio-Med USA, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Bio-Med USA, Inc.” (first 2008, latest 2022), 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-Med USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Med USA, Inc. is 156 days. Since 2017: 84 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bio-Med USA, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); FMF (Syringe, Piston, 2); LBI (Unit, Neonatal Phototherapy, 1).
Next steps
- See all 11 Bio-Med USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Bio-Med USA, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.