PMA · Approved
Recalled · Class II · 2022HeartStart OnSite Defibrillator (Model M5066A) and 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, Inc. · NSA Over-The-Counter Automated External Defibrillator
Approved on Jun 6, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 1,042-day review. It has been recalled 5 times.
- Decided
- Jun 6, 2019
- Review
- 1,042 days
- Class
- Class III
- Product code
- NSA
- Recalls
- 5
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160029 has 26 supplements since 2019: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 6 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2022 | Class II | Z-0882-2022 | Under Investigation by firm | There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost… |
| Feb 4, 2022 | Class II | Z-0881-2022 | Under Investigation by firm | There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost… |
| Jul 16, 2021 | Class II | Z-2427-2021 | Process control | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient |
| Feb 9, 2021 | Class II | Z-0080-2022 | Process control | Customers were not notified of previous recalls associated with various defibrillator models. |
| Feb 9, 2021 | Class II | Z-0081-2022 | Process control | Customers were not notified of previous recalls associated with various defibrillator models. |
No ancestor or descendant has a Class I recall.
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. 2019, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P160029 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160029: HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160029
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026