Bio Medicus, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Bio Medicus, Inc.” (first 1983, latest 1992), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 3 | 3 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| DWJ | System, Thermal Regulating | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| LIO | Device, Specimen Collection | 1 | 1 |
Review panels
- Cardiovascular (14)
- Microbiology (1)
Most recent Bio Medicus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE | LIO | 1992-06-19 | 121 |
| K903410 | BIO-MEDICUS CANNULA INTRODUCER | DYB | 1990-10-31 | 92 |
| K901253 | (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 | DTZ | 1990-09-05 | 173 |
| K901584 | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C | DWA | 1990-06-28 | 85 |
| K894980 | BIO-CAL 370 HEATER/COOLER | DWJ | 1989-11-02 | 86 |
| K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | DQY | 1988-12-21 | 82 |
| K883956 | BIO-MEDICUS TUBING CONNECTORS | DTL | 1988-10-28 | 39 |
| K872033 | BIO-MEDICUS CANNULA-TUBING | DWF | 1987-12-07 | 194 |
| K861096 | CARDIOPULMONARY CANNULA TUBING | DWF | 1986-05-21 | 58 |
| K854133 | BIO MEDICUS BIO CONSOLE 540 | DWA | 1986-01-08 | 90 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio Medicus, 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 Medicus, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Bio Medicus, Inc.” (first 1983, latest 1992), across 10 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 Medicus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Medicus, Inc. is 86 days.
Which FDA product codes appear under Bio Medicus, Inc.?
The most frequent FDA product codes under this applicant name are DWA (Control, Pump Speed, Cardiopulmonary Bypass, 3); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2).
Next steps
- See all 15 Bio Medicus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWA, Bio Medicus, 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.