Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
FDA 510(k) clearance K182503 · decided 2019-06-03
Clearance details
- K-number
- K182503
- Device name
- Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
- Applicant
- Physio-Control, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-12
- Decision date
- 2019-06-03
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION recall (Z-0142-2025) | Physio-Control, Inc. | 2024-10-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFEPAK® 35 Defibrillator/monitor (P160026/S063) | Physio-Control, Inc. | 2025-12-04 |
| LIFEPAK® 35 monitor/defibrillator (P160026/S064) | Physio-Control, Inc. | 2025-11-21 |
| LIFEPAK® CR2 Automated External Defibrillator (P170018/S023) | Physio-Control, Inc. | 2025-11-06 |
| LIFEPAK 1000 defibrillator (P160026/S062) | Physio-Control, Inc. | 2025-10-14 |
| LIFEPACK® CR2 Automated External Defibrillator (AED) (P170018/S024) | Physio-Control, Inc. | 2025-09-29 |
| LIFEPAK FLEX Lithium-ion Battery (P160026/S061) | Physio-Control, Inc. | 2025-06-30 |
| LIFEPAK® CR2 Defibrillator (P170018/S022) | Physio-Control, Inc. | 2025-06-20 |
| LIFEPAK 35 monitor/defibrillator (P160026/S059) | Physio-Control, Inc. | 2025-06-20 |