PHILIPS M5066A AND M5068A— 510(k) K020715
Substantially Equivalent - Subject to Tracking Reg.Philips Medical Systems
FDA 510(k) clearance K020715 for PHILIPS M5066A AND M5068A, Substantially Equivalent - Subject to Tracking Reg. on 2002-11-08. 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 - Subject to Tracking Reg.
- Clearance type
- Abbreviated
- Location
- Seattle, WA, US
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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 K020715
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-2549-2019 — Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
- Z-1914-2018 — Philips HeartStart (HS1) Onsite/Home AED
- Z-1232-2014 — Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
- Z-0643-2013 — Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 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 HS1 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 K020715.
Data sourced from openFDA. This site is unofficial and independent of the FDA.