# K020715: Philips M5066A and M5068A

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems
- Decided: Nov 8, 2002 after 248 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 7 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Heartstream FR2 AED: named in the summary without a submission number
- (no number) Cardiac Science/SurVivaLink Firstsave AED: named in the summary without a submission number
- (no number) Katecho Adult/Defibrillator/Pacing Electrodes: named in the summary without a submission number

## Most influential descendants
- K050004: Philips Heartstart FRX Defibrillator, Model 861304 (2005), 5 descendants of its own
- K072812: Philips Heartstart Smartpads Iii (2008), 3 descendants of its own
- K111693: Philips Heartstart FR3 Automated External Defibrillator (2011), 2 descendants of its own
- K040904: Philips Heartstart Home Defibrillator, Model M5068A (2004), 2 descendants of its own
- K041067: Heartsine Samaritan Pad (2004), 2 descendants of its own

## Recalls of this device
- Sep 10, 2019 · Class II · Z-1272-2020: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
- Sep 10, 2019 · Class II · Z-1271-2020: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
- Aug 8, 2018 · Class II · Z-2549-2019: The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrilla
- Mar 14, 2018 · Class II · Z-1914-2018: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
- Feb 6, 2014 · Class II · Z-1232-2014: Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamin
- Jul 26, 2012 · Class II · Z-0643-2013: Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A an
- Apr 30, 2010 · Not classified · Z-1916-2010: Seventeen AEDs failed production line testing (Final Acceptance Test).
- Apr 30, 2010 · Not classified · Z-1917-2010: Seventeen AEDs failed production line testing (Final Acceptance Test).
- Nov 2, 2009 · Not classified · Z-1194-2010: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- Nov 2, 2009 · Not classified · Z-1195-2010: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- Apr 30, 2008 · Not classified · Z-1780-2008: Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrill
- Apr 30, 2008 · Not classified · Z-1779-2008: Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrill

## Indications for use
The M5066A is designed to be used on a person in sudden cardiac arrest, who is: unresponsive when shaken, and not breathing normally. If in doubt, apply the pads. If the victim is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), you should use the special infanuchild pads. If the child appears olded/larger, use the adult pads. Do not delay treatment to determine the child’s exact age or weight. The M5066A is intended for use by people who have been specifically trained in its operation. A M5066A user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency medical response program in accordance with local and state requirements. Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician. The M5068A is designed to be used on a person who is in sudden cardiac arrest and who is: unresponsive when shaken, and not breathing normally. The defibrillator should not be used on a person who is: responsive when shaken, or breathing normally. If you are not certain if the person is in sudden cardiac arrest, apply the defibrillator and follow its instructions. For children 8 years or older, or who weigh 55 pounds or more, use the M5068A with the adult pads that come with it. For younger children to those who weigh less than 55 pounds, the special infadchild pads should be used. When used with these pads, the M5068A delivers a lower energy appropriate for infants and small children. The M5068A is intended for use by people who have been specifically trained in its operation. The user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency response program in accordance with local and state requirements. Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.

Source page: https://510kreport.com/device/K020715
Methodology: https://510kreport.com/methodology