LIFEPAK Automated External Defibrillator (AED)
FDA premarket approval P160026/S031 · decided 2022-07-28
Approval details
- PMA number
- P160026
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEPAK Automated External Defibrillator (AED)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Physio-Control, Inc.
- Date received
- 2022-05-13
- Decision date
- 2022-07-28
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Approval for design changes to support integration of the nanoMediCO2 capnography (EtCO2) module and software changes intended to mitigate an unexpected anomaly related to the Service LED function of the LIFEPAK 15 Monitor/Defibrillator device.
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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 |