Medtronic Hemotec, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medtronic Hemotec, Inc.” (first 1992, latest 1996), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 213 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 |
|---|---|---|---|
| GFT | Protamine Sulphate | 1 | 1 |
| GKN | Timer, Clot, Automated | 1 | 1 |
| JBP | Activated Whole Blood Clotting Time | 1 | 1 |
| JOX | Analyzer, Heparin, Automated | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
Review panels
- Hematology (5)
Most recent Medtronic Hemotec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954202 | PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS | JPA | 1996-06-20 | 287 |
| K944115 | HEPARIN ASSAY CARTRIDGES AND CONTROLS | GFT | 1995-03-24 | 213 |
| K940426 | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | GKN | 1994-09-20 | 232 |
| K923594 | CLOTTRAC COAGULATION CONTROL | JBP | 1992-09-21 | 63 |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | JOX | 1992-07-21 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Hemotec, 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 Hemotec, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medtronic Hemotec, Inc.” (first 1992, latest 1996), across 5 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 Hemotec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Hemotec, Inc. is 213 days.
Which FDA product codes appear under Medtronic Hemotec, Inc.?
The most frequent FDA product codes under this applicant name are GFT (Protamine Sulphate, 1); GKN (Timer, Clot, Automated, 1); JBP (Activated Whole Blood Clotting Time, 1).
Next steps
- See all 5 Medtronic Hemotec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GFT, Medtronic Hemotec, 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.