510(k) · Cleared
Recalled · Class II · 2019Philips Heartstart Home Defibrillator, Model M5068A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · NSA Over-The-Counter Automated External Defibrillator
Cleared on Sep 16, 2004 as substantially equivalent to K020715 (Philips Medical Systems, 2002) and 1 other predicate after a 162-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Sep 16, 2004
- Review
- 162 days
- Class
- Class III
- Product code
- NSA
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003565 (2000). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003565 Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc. · 2000 · Recalled
- This deviceK040904 Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 2004
- Descendant · cites it directly · 0 of its ownK120350 Extended Life BatteryAed Battery Exchange, LLC · 2012
- Descendant · cites it directly · 0 of its ownK091548 Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003565 | Heartstream FR2 Aed, Model M3860A,M3861A | Agilent Technologies, Inc. | 2000 | 12 |
| 0 (this device) | K040904 | Philips Heartstart Home Defibrillator, Model M5068A | Philips Medical Systems | 2004 | — |
| +1 | K120350 | Extended Life Battery | Aed Battery Exchange, LLC | 2012 | — |
| +1 | K091548 | Amco Replacement Battery for Philips Medical Models BT1 and M5070A | Amco International Manufacturing & Design, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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.
Planning a device in NSA? 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? (2)
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 |
|---|---|---|---|
| * | K020715 | Philips M5066A and M5068ASummary page 3…Philips Medical Systems, Heartstream claims equivalence for the HeartS tart Home OTC Defibrillator is the HeartStart Home Rx Defibrillator (cleared under K020715) and the FR2 Defibrillator (cleared under K003565). Philips Medical Systems K… | 2002 |
| * | K003565 | Heartstream FR2 Aed, Model M3860A,M3861ASummary page 3…equivalence for the HeartS tart Home OTC Defibrillator is the HeartStart Home Rx Defibrillator (cleared under K020715) and the FR2 Defibrillator (cleared under K003565). Philips Medical Systems K040904 510(k) Summary HeartStart Home OTC Defibril… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 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. |
| 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… |
| 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-1196-2010 | 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-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… |
| Apr 30, 2008 | Not classified | Z-1781-2008 | 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 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NSA devicesNSA Over-The-Counter Automated External Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NSA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NSA
Too few NSA 510(k)s in any year since 2007 to give a median.
Recalls per year · NSA
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NSA
568in 2025
MAUDE reports naming product code NSA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 40 |
| 2013 | 0 | — | 0 | 108 |
| 2014 | 0 | — | 0 | 177 |
| 2015 | 0 | — | 0 | 62 |
| 2016 | 0 | — | 0 | 44 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 0 | — | 0 | 69 |
| 2019 | 2 | — | 0 | 54 |
| 2020 | 4 | — | 0 | 39 |
| 2021 | 6 | — | 0 | 20 |
| 2022 | 5 | — | 0 | 23 |
| 2023 | 4 | — | 0 | 67 |
| 2024 | 4 | — | 0 | 92 |
| 2025 | 2 | — | 0 | 568 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HeartStart Home Defibrillator should be used to treat someone who you think may be a
victim of sudden cardiac arrest. A person in sudden cardiac arrest:
• does not respond when shaken, and
• is not breathing normally.
If in doubt, apply the pads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040904: Philips Heartstart Home Defibrillator, Model M5068A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040904
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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