PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304— 510(k) K050004
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K050004 for PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304, Substantially Equivalent on 2005-02-25. Applicant: Philips Medical Systems. Device class: 3.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code MKJ
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seattle, WA, US
Recent devices under product code MKJ
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Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K050004
K-number listed on FDA's recall record- Z-1271-2020 — Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
- Z-1272-2020 — Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
- Z-1913-2018 — Philips HeartStart FRx AED.
- Z-0642-2013 — Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050004.
Data sourced from openFDA. This site is unofficial and independent of the FDA.