HeartStart OnSite Defibrillator M5066A and HeartStart Home Defibrillator M5068A

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P160029510(k) K040904

by Philips Medical Systems, Inc.

Identity

Trade Name: HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) FDA PMA
Generic Name: Over-the-counter automated external defibrillator FDA PMA

Identifiers

PMA Number: P160029 FDA PMA
510(k) Number: K040904 FDA PMA
FDA Product Code: NSA FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 870.5310 FDA PMA
Regulation Number: 870.5310 FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) are over-the-counter automated external defibrillators. These devices are indicated for use on potential victims of sudden cardiac arrest who are unconscious and not breathing normally.

Both models are indicated for adults weighing over 55 pounds (25 kg). For infants and children under 55 pounds or 8 years of age, the devices are used with optional infant/child SMART pads. If specific pediatric pads are unavailable or the child's weight is uncertain, treatment may be performed using adult SMART pads.

Frequently asked questions

What are the HeartStart OnSite and Home defibrillators used for?

These devices are indicated for use on potential victims of sudden cardiac arrest who exhibit symptoms of unconsciousness and an absence of normal breathing.

Can these defibrillators be used on children?

Yes, both models are indicated for infants and children under 55 pounds or 8 years old when used with optional infant/child SMART pads. If these pads are not available or the child's weight is uncertain, adult SMART pads may be used.

What is the weight requirement for adult use?

The HeartStart OnSite and Home defibrillators are indicated for use on adults weighing over 55 pounds (25 kg).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips HeartStart Home and Onsite Automated ... - Amazon.com, P160029 - Premarket Approval (PMA) - FDA, HeartStart Home AED with Training Pads - Philips, Philips HeartStart Home and OnSite (HS1) AEDs : Biomedical Safety ..., Philips HeartStart OnSite Demonstration & Training Video

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K040904	Class III	Active
FDA 510(k)	United States	FDA_510K	K020715	Class III	Active
FDA PMA	United States	FDA_PMA	P160029	Class III	Active

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Manufacturer

Manufacturer: Philips Medical Systems, Inc.
FDA Applicant: Philips Medical Systems

Sources (2)

FDA PMA P160029 37 fields · synced Sep 18, 2026
FDA 510(k) K040904 1 fields · synced May 18, 2026