510(k) · Cleared
Recalled · Class II · 2019Philips M5066A and M5068A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Nov 8, 2002 after a 248-day review. The FDA summary names its predicate without a number. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled 12 times.
- Decided
- Nov 8, 2002
- Review
- 248 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 12
- Predicates
- 0
12 later devices descend from it, 7 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- This deviceK020715 Philips M5066A and M5068APhilips Medical Systems · 2002
- Descendant · cites it directly · 5 of its ownK050004 Philips Heartstart FRX Defibrillator, Model 861304Philips Medical Systems · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK072812 Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008
- Descendant · 3 generations on · 2 of its ownK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK040904 Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 2004 · Recalled
- Descendant · cites it directly · 2 of its ownK041067 Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K041067 Heartsine Samaritan Padcites it directly · 2004
Most influential descendants
Showing 5 of 12 · See all- K050004Philips Heartstart FRX Defibrillator, Model 861304Philips Medical Systems · 2005 · cites it directly5descendants
- K072812Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008 · 2 generations on3descendants
- K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · 3 generations on2descendants
- K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 2004 · cites it directly2descendants
- K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020715 | Philips M5066A and M5068A | Philips Medical Systems | 2002 | — |
| +1 | K050004 | Philips Heartstart FRX Defibrillator, Model 861304 | Philips Medical Systems | 2005 | 7 |
| +2 | K072812 | Philips Heartstart Smartpads Iii | Philips Medical Systems | 2008 | — |
| +3 | K111693 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2011 | 1 |
| +1 | K040904 | Philips Heartstart Home Defibrillator, Model M5068A | Philips Medical Systems | 2004 | 7 |
| +1 | K041067 | Heartsine Samaritan Pad | Heartsine Technologies, Inc. | 2004 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Heartstream FR2 AED Named without a submission number | |
| * | — | Cardiac Science/SurVivaLink Firstsave AED Named without a submission number | |
| * | — | Katecho Adult/Defibrillator/Pacing Electrodes Named without a submission number |
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050004 | Philips Heartstart FRX Defibrillator, Model 861304 | 2005 | 5 |
| K040904 | Philips Heartstart Home Defibrillator, Model M5068A | 2004 | 2 |
| K041067 | Heartsine Samaritan Pad Class I | 2004 | 2 |
| K120350 | Extended Life Battery | 2012 | 0 |
| K091548 | Amco Replacement Battery for Philips Medical Models BT1 and M5070A | 2009 | 0 |
| K062970 | I-PAD | 2008 | 0 |
| K042088 | Samaritan Pad Pak Defibrillation Electrode, Model SPP-301 | 2004 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2019 | Class II | Z-1272-2020 | Process control | 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 | Process control | 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 | Labeling False and Misleading | 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 defibrillator An Infant/Child pad cartridge… |
| Mar 14, 2018 | Class II | Z-1914-2018 | Nonconforming Material/Component | 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 | Vendor change control | 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 contamination could prevent an adequate… |
| Jul 26, 2012 | Class II | Z-0643-2013 | Nonconforming Material/Component | 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 and M5067A), or HeartStart Home (model… |
| Apr 30, 2010 | Not classified | Z-1916-2010 | Nonconforming Material/Component | Seventeen AEDs failed production line testing (Final Acceptance Test). |
| Apr 30, 2010 | Not classified | Z-1917-2010 | Nonconforming Material/Component | Seventeen AEDs failed production line testing (Final Acceptance Test). |
| Nov 2, 2009 | Not classified | Z-1194-2010 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Component design/selection | 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 defibrillation shock when the system advises a… |
| Apr 30, 2008 | Not classified | Z-1779-2008 | Component design/selection | 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 defibrillation shock when the system advises a… |
The 5 latest of 12 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K050004 (Philips Medical Systems, 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
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…
Read the full statement (316 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020715: Philips M5066A and M5068A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020715
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026