510(k) · Cleared
Recalled · Class II · 2021Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A, M3841A
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 Oct 5, 2005 after a 107-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 5, 2005
- Review
- 107 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 7
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK051632 Philips Heartstart FR2+ Automated External Defibrillator, Models…Philips Medical Systems · 2005
- Descendant · cites it directly · 10 of its ownK072923 Zoll E Series DefibrillatorZoll Medical Corporation, World Wide Headquarters · 2008
- Descendant · 2 generations on · 8 of its ownK112432 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · Recalled
- Descendant · 3 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
- Descendant · 3 generations on · 3 of its ownK121367 Zoll Propaq XMZOLL Medical Corporation · 2012 · Recalled
- Descendant · 4 generations on · 2 of its ownK180482 ZOLL Propaq MZOLL Medical Corporation · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K072923Zoll E Series DefibrillatorZoll Medical Corporation, World Wide Headquarters · 2008 · cites it directly10descendants
- K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 2 generations on8descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 3 generations on4descendants
- K121367Zoll Propaq XMZOLL Medical Corporation · 2012 · 3 generations on3descendants
- K180482ZOLL Propaq MZOLL Medical Corporation · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051632 | Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A… | Philips Medical Systems | 2005 | — |
| +1 | K072923 | Zoll E Series Defibrillator | Zoll Medical Corporation, World Wide Headquarters | 2008 | — |
| +2 | K112432 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | 2 |
| +3 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
| +3 | K121367 | Zoll Propaq XM | ZOLL Medical Corporation | 2012 | 1 |
| +4 | K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 MKJ? 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? (1)
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 |
|---|---|---|---|
| * | — | Philips/Heartstream HeartStart FR2+ AED Named without a submission number |
What descends from it? (14)
See all 143 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 |
|---|---|---|---|---|
| Feb 9, 2021 | Class II | Z-0078-2022 | Process control | Customers were not notified of previous recalls associated with various defibrillator models. |
| May 28, 2010 | Not classified | Z-0470-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| May 28, 2010 | Not classified | Z-0472-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| May 28, 2010 | Not classified | Z-0473-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| May 28, 2010 | Not classified | Z-0471-2011 | Nonconforming Material/Component | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. |
| Oct 1, 2009 | Not classified | Z-0062-2010 | Nonconforming Material/Component | A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy. |
| Oct 1, 2009 | Not classified | Z-0063-2010 | Nonconforming Material/Component | A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy. |
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?
- Of its descendants, K072923 (Zoll Medical Corporation, World Wide Headquarters, 2008) has gone furthest, with 10 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 HeartStart FR2+ is intended to be used with disposable defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing. If in doubt, apply the pads. When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available. WARNING: Performance of the SMART CPR AUTOl and AUTO2 settings has not been…
Read the full statement (199 words)
The HeartStart FR2+ is intended to be used with disposable defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing.
If in doubt, apply the pads.
When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available.
WARNING: Performance of the SMART CPR AUTOl and AUTO2 settings has not been established in patients under 8 years or 55 lb (25 kg). See Appendix E for more information.
The HeartStart FR2+ is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support (BLS), advanced life support (ALS), or other physician-authorized emergency medical response.
At the discretion of emergency care personnel, the M3860A FR2+ with ECG display enabled can also be used with the FR2+ ECG assessment module to display the rhythm of a responsive or breathing patient, regardless of age. The FR2+ and ECG assessment module system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2+ ECG assessment module, the FR2+ evaluates the patient's ECG and disables its shock capability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051632: Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A, M3841A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051632
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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