Medtronic Blood Systems, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Medtronic Blood Systems, Inc.” (first 1988, latest 1995), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 4 | 4 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 3 | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| LDF | Electrode, Pacemaker, Temporary | 2 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
| KRH | Ring, Annuloplasty | 1 | 1 |
Review panels
- Cardiovascular (15)
Most recent Medtronic Blood Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944966 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 | LDF | 1995-07-14 | 276 |
| K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 | LDF | 1995-07-14 | 280 |
| K893207 | CLOSED CHEST SUPPORT CIRCUIT | DTZ | 1989-12-12 | 230 |
| K893678 | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H | KRH | 1989-11-27 | 195 |
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE | DTZ | 1989-05-31 | 70 |
| K891230 | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. | DTZ | 1989-05-19 | 73 |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | KRJ | 1989-02-22 | 69 |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | KRJ | 1988-12-21 | 64 |
| K884244 | INTERSEPT* PREBYPASS FILTER | KRJ | 1988-12-05 | 55 |
| K883439 | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM | DTR | 1988-10-13 | 59 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Blood Systems, 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 PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
- Medtronic Bio-Medicus, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Blood Systems, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Medtronic Blood Systems, Inc.” (first 1988, latest 1995), across 8 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 Blood Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Blood Systems, Inc. is 73 days.
Which FDA product codes appear under Medtronic Blood Systems, Inc.?
The most frequent FDA product codes under this applicant name are KRJ (Filter, Prebypass, Cardiopulmonary Bypass, 4); DTZ (Oxygenator, Cardiopulmonary Bypass, 3); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 2).
Next steps
- See all 15 Medtronic Blood Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRJ, Medtronic Blood Systems, 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.