Medtronic Bio-Medicus, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Medtronic Bio-Medicus, Inc.” (first 1992, latest 1998), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 211 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
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 | 6 | 6 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 | 1 |
Review panels
- Cardiovascular (13)
Most recent Medtronic Bio-Medicus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | DWB | 1998-04-27 | 242 |
| K973011 | BPX80 BIO-PUMP (BPX80) | KFM | 1998-02-25 | 196 |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | DTY | 1996-01-16 | 110 |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | DRY | 1995-02-17 | 303 |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER | DWA | 1994-12-23 | 366 |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | DWA | 1994-07-20 | 91 |
| K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) | DPT | 1993-07-08 | 322 |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | DWA | 1993-06-02 | 163 |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | DWA | 1993-05-07 | 260 |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | DWA | 1993-05-06 | 259 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtronic 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.
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.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Bio-Medicus, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Medtronic Bio-Medicus, Inc.” (first 1992, latest 1998), across 7 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 Medtronic Bio-Medicus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Bio-Medicus, Inc. is 211 days.
Which FDA product codes appear under Medtronic Bio-Medicus, Inc.?
The most frequent FDA product codes under this applicant name are DWA (Control, Pump Speed, Cardiopulmonary Bypass, 6); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2); DPT (Probe, Blood-Flow, Extravascular, 1).
Next steps
- See all 13 Medtronic Bio-Medicus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWA, Medtronic 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.