PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
FDA 510(k) clearance K040904 · decided 2004-09-16
Clearance details
- K-number
- K040904
- Device name
- PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2004-04-07
- Decision date
- 2004-09-16
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- NSA
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product recall (Z-1232-2014) | Philips Medical Systems North America Inc. | 2014-03-19 |
| Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model recall (Z-1917-2010) | Philips Medical Systems | 2010-06-28 |
| Heartstart HS1 Defibrillator Model M5068A recall (Z-1196-2010) | Philips Medical Systems | 2010-03-23 |
| Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand n recall (Z-1779-2008) | Philips Medical Systems | 2008-07-09 |
| Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the count recall (Z-1781-2008) | Philips Medical Systems | 2008-07-09 |
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 |