LIFEPAK Automated External Defibrillators (AEDs)
FDA premarket approval P160026/S015 · decided 2021-07-08
Approval details
- PMA number
- P160026
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEPAK Automated External Defibrillators (AEDs)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Physio-Control, Inc.
- Date received
- 2020-01-30
- Decision date
- 2021-07-08
- Days to decision
- 525 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Approval for the Infant/Child Reduced Energy Defibrillation Electrodes for use with the LIFEPAK 1000, LIFEPAK CR Plus, and LIFEPAK EXPRESS defibrillators.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 15 AC Power Adapter (41577-000333) (K253099) | Physio-Control, Inc. | 2025-10-14 |
| 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) (K240156) | Physio-Control, Inc. | 2024-04-30 |
| Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503) | Physio-Control, Inc. | 2019-06-03 |
| LIFEPAK 15 monitor/defibrillator (K142430) | Physio-Control, Inc. | 2014-12-19 |
| LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454) | Physio-Control, Inc. | 2013-08-21 |
| TRUECPR COACHING DEVICE (K123597) | Physio-Control, Inc. | 2013-04-17 |
| LIFEPAK 1000 DEFIBRILLATOR (K122600) | Physio-Control, Inc. | 2012-10-11 |
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567) | Physio-Control, Inc. | 2011-03-22 |