510(k) · Cleared
Recalled · 2010Heartstream/Heartstart FR2 Aed Ecg Cable, 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 Jan 14, 2002 after a 90-day review. The FDA summary names its predicate without a number. 2 of the 41 devices in its family, counting itself, have a Class I recall. 40 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 14, 2002
- Review
- 90 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 10
- Predicates
- 0
40 later devices descend from it, 9 citing it directly. 2 of the 41 devices in this family, counting this one, have a Class I recall.
- This deviceK013425 Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A…Philips Medical Systems · 2002
- Descendant · cites it directly · 23 of its ownK041892 Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005
- Descendant · 2 generations on · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- Descendant · 3 generations on · 11 of its ownK100654 Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010
- Descendant · 3 generations on · 9 of its ownK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
- Descendant · 4 generations on · 9 of its ownK102468 Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 40 · See all- K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005 · cites it directly23descendants
- K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · 2 generations on21descendants
- K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010 · 3 generations on11descendants
- K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · 3 generations on9descendants
- K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013425 | Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A | Philips Medical Systems | 2002 | — |
| +1 | K041892 | Zoll Aed Pro External Defibrillator | ZOLL Medical Corporation | 2005 | — |
| +2 | K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | 2006 | 1 |
| +3 | K100654 | Zoll Propaq MD | Zoll Medical Corporation, World Wide Headquarters | 2010 | — |
| +3 | K110742 | Onestep Adult Multi-Function Electrode | ZOLL Medical Corporation | 2011 | 1 |
| +4 | K102468 | Zoll Propaq MD | Zoll Medical Corporation, World Wide Headquarters | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 1 |
| 2008 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 1 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 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.
2 devices in this family have 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? (4)
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 | |
| * | — | Laerdal Heartstart 3000 Named without a submission number | |
| * | — | Heartstream XLT Defibrillator/Monitor Named without a submission number | |
| * | — | Active Corporation ActiveECG device Named without a submission number |
What descends from it? (40)
See all 409 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041892 | Zoll Aed Pro External Defibrillator | 2005 | 23 |
| K052057 | Lifepak 500 Automated External Defibrillator | 2006 | 4 |
| K040637 | Powerheart Aed G3 Pro | 2004 | 3 |
| K042404 | Lifepak, Model 1000 | 2005 | 1 |
| K130684 | Philips Heartstart FR3 Automated External Defibrillator | 2013 | 0 |
| K121853 | Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories | 2012 | 0 |
| K120350 | Extended Life Battery | 2012 | 0 |
| K073716 | Life+Cel or Lifecel Battery | 2008 | 0 |
| K062970 | I-PAD | 2008 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2010 | Not classified | Z-0487-2011 | Nonconforming Material/Component | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. |
| Sep 22, 2010 | Not classified | Z-0483-2011 | Nonconforming Material/Component | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. |
| Sep 22, 2010 | Not classified | Z-0485-2011 | Nonconforming Material/Component | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. |
| Sep 22, 2010 | Not classified | Z-0486-2011 | Nonconforming Material/Component | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. |
| Sep 22, 2010 | Not classified | Z-0488-2011 | Nonconforming Material/Component | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. |
| Sep 22, 2010 | Not classified | Z-0484-2011 | Nonconforming Material/Component | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. |
| 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. |
The 5 latest of 10 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.
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K041892 (ZOLL Medical Corporation, 2005) has gone furthest, with 23 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 FR2 is intended to be used with disposable Heartstream defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing. When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads. The FR2 is intended for use by personnel who have been trained in its operation. The user should be…
Read the full statement (161 words)
The FR2 is intended to be used with disposable Heartstream defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing.
When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads.
The 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 Cable to display the rhythm of a responsive or breathing patient, regardless of age. The FR2 and ECG Cable system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2 ECG Cable, the FR2 evaluates the patient’s ECG and disables it’s shock capability.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013425
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026