LIFEPAK 15 MONITOR/DEFIBRILLATOR
FDA 510(k) clearance K103567 · decided 2011-03-22
Clearance details
- K-number
- K103567
- Device name
- LIFEPAK 15 MONITOR/DEFIBRILLATOR
- Applicant
- Physio-Control, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-06
- Decision date
- 2011-03-22
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFEPAK® 35 monitor/defibrillator (P160026/S071) | Physio-Control, Inc. | 2026-08-06 |
| LIFEPAK® CR2 Defibrillator (P170018/S025) | Physio-Control, Inc. | 2026-07-30 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026/S070) | Physio-Control, Inc. | 2026-07-30 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S068) | Physio-Control, Inc. | 2026-06-25 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S067) | Physio-Control, Inc. | 2026-05-06 |
| LIFEPAK 35 monitor/defibrillator (P160026/S066) | Physio-Control, Inc. | 2026-03-05 |
| LIFEPAK® 35 monitor/defibrillator (P160026/S065) | Physio-Control, Inc. | 2026-02-23 |
| LIFEPAK® 35 Defibrillator/monitor (P160026/S063) | Physio-Control, Inc. | 2025-12-04 |