PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
FDA 510(k) clearance K110825 · decided 2012-02-16
Clearance details
- K-number
- K110825
- Device name
- PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-03-23
- Decision date
- 2012-02-16
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HeartStart XL+ Defibrillator/Monitor, Model 861290 recall (Z-0498-2020) | Philips North America, LLC | 2019-11-19 |
| Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended recall (Z-2328-2015) | Philips Electronics North America Corporation | 2015-08-04 |
| Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00. recall (Z-1438-2014) | Philips Medical Systems, Inc. | 2014-04-09 |
| Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defi recall (Z-1439-2014) | Philips Medical Systems, Inc. | 2014-04-09 |
| Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended recall (Z-1107-2014) | Philips Medical Systems, Inc. | 2014-02-26 |
| Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is in recall (Z-0871-2013) | Philips Healthcare Inc. | 2013-02-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |