510(k) · Cleared
Recalled · Class II · 2019Philips Heartstart FRX Defibrillator, Model 861304
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 Feb 25, 2005 as substantially equivalent to K020715 (Philips Medical Systems, 2002) after a 54-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 25, 2005
- Review
- 54 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020715 (2002). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK020715 Philips M5066A and M5068APhilips Medical Systems · 2002 · Recalled
- This deviceK050004 Philips Heartstart FRX Defibrillator, Model 861304Philips Medical Systems · 2005
- Descendant · cites it directly · 3 of its ownK072812 Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008
- Descendant · 2 generations on · 2 of its ownK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK130684 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013 · Recalled
- 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 5 of 5 · See all- K072812Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008 · cites it directly3descendants
- K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · 2 generations on2descendants
- K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013 · 3 generations on0descendants
- K120350Extended Life BatteryAed Battery Exchange, LLC · 2012 · cites it directly0descendants
- K091548Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020715 | Philips M5066A and M5068A | Philips Medical Systems | 2002 | 12 |
| 0 (this device) | K050004 | Philips Heartstart FRX Defibrillator, Model 861304 | Philips Medical Systems | 2005 | — |
| +1 | K072812 | Philips Heartstart Smartpads Iii | Philips Medical Systems | 2008 | — |
| +2 | K111693 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2011 | 1 |
| +3 | K130684 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2013 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K020715 | Philips M5066A and M5068A | 2002 |
What descends from it? (5)
3 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. |
| Mar 14, 2018 | Class II | Z-1913-2018 | Nonconforming Material/Component | An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. |
| Jul 26, 2012 | Class II | Z-0642-2013 | Nonconforming Material/Component | Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model… |
| Apr 30, 2010 | Not classified | Z-1915-2010 | Nonconforming Material/Component | Seventeen AEDs failed production line testing (Final Acceptance Test). |
| Nov 2, 2009 | Not classified | Z-1193-2010 | Nonconforming Material/Component | Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated. |
| Aug 7, 2008 | Not classified | Z-0432-2011 | Employee error | The affected device may not deliver appropriate defibrillation 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?
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 FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:
* Unresponsive when shaken
* Not breathing normally
If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator.
If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050004: Philips Heartstart FRX Defibrillator, Model 861304.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050004
Report an extraction error
Are you the manufacturer?
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