Medtronic Physio-Control Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medtronic Physio-Control Corp.” (first 2001, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 134 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 Stryker, 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 7 | 7 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Medtronic Physio-Control Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040775 | LIFEPAK 12 | MKJ | 2004-04-23 | 28 |
| K033275 | LIFEPAK 12, 20, 500, CR PLUS | MKJ | 2003-11-06 | 27 |
| K022732 | INFANT/CHILD REDUCED ENERGY ELECTRODES | MKJ | 2002-12-13 | 119 |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | 2002-02-05 | 201 |
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | 2001-12-03 | 231 |
| K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | 2001-09-28 | 59 |
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | MKJ | 2001-08-23 | 149 |
| K002445 | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES | MKJ | 2001-01-31 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Physio-Control Corp..
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 Physio-Control Corp.?
FDA lists 8 510(k) clearances under the applicant name “Medtronic Physio-Control Corp.” (first 2001, latest 2004), across 2 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 Physio-Control Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Physio-Control Corp. is 134 days.
Which FDA product codes appear under Medtronic Physio-Control Corp.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 7); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 1).
Next steps
- See all 8 Medtronic Physio-Control Corp. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Medtronic Physio-Control Corp.'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.