Physio-Control Corp.: FDA clearances and approvals
Physio-Control Corp. has 94 FDA 510(k) clearances (first 1976, latest 2025), plus 3 PMA decisions, across 28 product codes in 7 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 102 days, against 182 days for all cleared 510(k)s in the same product codes. openFDA lists 41 product recalls by a recalling firm named Physio-Control Corp. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 45 |
| 2013 | 2 | 164 |
| 2014 | 1 | 112 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 264 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 102 |
| 2025 | 1 | 20 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Physio-Control Corp.'s cleared 510(k)s took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 21 | 18 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 17 | 17 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 10 | 10 |
| DPS | Electrocardiograph | 5 | 5 |
| DRX | Electrode, Electrocardiograph | 5 | 5 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 | 5 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| DSF | Recorder, Paper Chart | 3 | 3 |
| IOL | Treadmill, Powered | 2 | 2 |
Plus 18 more product codes.
Review panels
- Cardiovascular (84)
- Gastroenterology and Urology (5)
- Anesthesiology (2)
- Physical Medicine (2)
- Dental (1)
- Neurology (1)
- Clinical Toxicology (1)
Most recent Physio-Control Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | MPD | 2025-10-14 | 20 |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | DSA | 2024-04-30 | 102 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | LDD | 2019-06-03 | 264 |
| K142430 | LIFEPAK 15 monitor/defibrillator | MKJ | 2014-12-19 | 112 |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | MKJ | 2013-08-21 | 180 |
| K123597 | TRUECPR COACHING DEVICE | LIX | 2013-04-17 | 147 |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | MKJ | 2012-10-11 | 45 |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | 2011-03-22 | 106 |
| K102972 | LIFEPAK 12 | MKJ | 2010-12-22 | 77 |
| K102757 | LIFENET SYSTEM | MSX | 2010-11-05 | 43 |
84 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170018 | PMA | LIFEPAK® CR2 Defibrillator | 2018-12-21 |
| P160026 | PMA | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE | 2018-07-02 |
| P160012 | PMA | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger | 2017-12-21 |
Recalls
41 product recalls in 25 recall events; 22 initiated in the last five years. Most recent: 2026-04-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Physio-Control Corp. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02479152: The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR (Completed, started 2015-04)
Frequently asked questions
How many FDA 510(k) clearances does Physio-Control Corp. have?
Physio-Control Corp. has 94 FDA 510(k) clearances (first 1976, latest 2025), plus 3 PMA decisions, across 28 product codes in 7 review panels.
How long does FDA take to clear Physio-Control Corp.'s 510(k)s?
The median time from FDA receipt to decision across Physio-Control Corp.'s cleared 510(k)s is 90 days. Since 2017: 102 days, versus 182 days for all cleared 510(k)s in the same product codes.
What devices does Physio-Control Corp. make?
Its most frequent FDA product codes are MKJ (Automated External Defibrillators (Non-Wearable), 21); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 17); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 10).
Has Physio-Control Corp. had device recalls?
openFDA lists 41 product recalls in 25 recall events by a recalling firm whose name matches Physio-Control Corp; the most recent began 2026-04-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 94 Physio-Control Corp. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Physio-Control Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.