HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
FDA 510(k) clearance K133659 · decided 2015-01-23
Clearance details
- K-number
- K133659
- Device name
- HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2013-11-27
- Decision date
- 2015-01-23
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, 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.
| Record | Firm | Date |
|---|---|---|
| Powerheart G5 AED (K143714) | Cardiac Science Corporation | 2015-05-04 |
| CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198) | Bio-Detek, Inc. | 2015-05-02 |
| OneStep Pediatric CPR Multi-Function Electrode (K150055) | Bio-Detek, Inc. | 2015-05-02 |
| samaritan PAD 450P (K142709) | Heartsine Technologies, Inc. | 2015-03-27 |
| ZOLL E SERIES (K133239) | Zoll Medical Corporation, World Wide Headquarters | 2015-01-16 |
| LIFEPAK 15 monitor/defibrillator (K142430) | Physio-Control, Inc. | 2014-12-19 |
| BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795) | R & D Batteries, Inc. | 2014-12-08 |
| ZOLL X Series (K142915) | ZOLL Medical Corporation | 2014-12-03 |
| Skintact, various other tradenames (K142803) | Leonhard Lang GmbH | 2014-12-02 |
| ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231) | Zeller Power Products (Battery Beast, LLC) | 2014-11-25 |
| ZOLL X SERIES (K141774) | ZOLL Medical Corporation | 2014-11-19 |
| ONESTEP CPR II MULTI-FUNCTION ELECTRODE (K133441) | Bio-Detek, Inc. | 2014-10-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator (861304) (P180028/S019) | Philips Medical Systems | 2026-05-21 |
| HeartStart FRx Defibrillator (P180028/S018) | Philips Medical Systems | 2026-02-02 |
| 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 |