510(k) · Cleared
Recalled · 2010HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, 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 17, 2002 after a 29-day review. The FDA summary names its predicate without a number. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 17, 2002
- Review
- 29 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 4
- Predicates
- 0
9 later devices descend from it, 4 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK014157 HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861…Philips Medical Systems · 2002
- Descendant · cites it directly · 3 of its ownK040637 Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · Recalled
- Descendant · cites it directly · 2 of its ownK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · cites it directly · 1 of its ownK042404 Lifepak, Model 1000Medtronic Emergency Response Systems, Inc. · 2005 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K122600 Lifepak 1000 Defibrillator2 generations on · 2012
Most influential descendants
Showing 5 of 9 · See all- K040637Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · cites it directly3descendants
- K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · cites it directly2descendants
- K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation · 2011 · 2 generations on2descendants
- K122758Powerheart G5 AedCardiac Science Corporation · 2014 · 3 generations on1descendant
- K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc. · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014157 | HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A | Philips Medical Systems | 2002 | — |
| +1 | K040637 | Powerheart Aed G3 Pro | Cardiac Science, Inc. | 2004 | 8 |
| +1 | K111693 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2011 | 1 |
| +2 | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed… | Cardiac Science Corporation | 2011 | 2 |
| +3 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +1 | K042404 | Lifepak, Model 1000 | Medtronic Emergency Response Systems, Inc. | 2005 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 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? (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 |
|---|---|---|---|
| * | — | Heartstream FR2 AED Named without a submission number | |
| * | — | Medtronic/Physio-Control LifePak 500 Named without a submission number |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
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
What does this lineage say?
- Of its descendants, K040637 (Cardiac Science, Inc., 2004) has gone furthest, with 3 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 Heartstream FR2 is indicated for use on persons experiencing the symptoms of sudden cardiac arrest:
Lack of responsiveness
Lack 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. DO NOT DELAY TREATMENT TO DETERMINE THE CHILD’S EXACT AGE/WEIGHT.
The Heartstream 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, advanced life support, or other physician-authorized emergency medical response.
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/K014157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014157: HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, 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/K014157
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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