510(k) · Cleared
Recalled · Class II · 2014Philips Heartstart FR3 Automated External Defibrillator
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 28, 2011 as substantially equivalent to K003565 (Agilent Technologies, Inc., 2000) and 4 other predicates after a 134-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 28, 2011
- Review
- 134 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 3 generations to K020715 (2002). 7 ancestors in all, the oldest K003565 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK020715 Philips M5066A and M5068APhilips Medical Systems · 2002 · Recalled
- 2 generations backK050004 Philips Heartstart FRX Defibrillator, Model 861304Philips Medical Systems · 2005 · Recalled
- 1 generation backK072812 Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008
- This deviceK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011
- Descendant · cites it directly · 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020715 | Philips M5066A and M5068A | Philips Medical Systems | 2002 | 12 |
| −2 | K050004 | Philips Heartstart FRX Defibrillator, Model 861304 | Philips Medical Systems | 2005 | 7 |
| −1 | K072812 | Philips Heartstart Smartpads Iii | Philips Medical Systems | 2008 | — |
| 0 (this device) | K111693 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2011 | — |
| +1 | K130684 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2013 | 1 |
| +1 | K120350 | Extended Life Battery | Aed Battery Exchange, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K050040 | FDA’s K050040 is MS-753 Mars Inflate-Read Blood Pressure Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | K003565 | Heartstream FR2 Aed, Model M3860A,M3861ASummary page 2…ream Traditional 510(k) PreMarket Notification Section IS, page 1 of 3 861388 and 861389 HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K 003565, #K 003819, #K014157 and #K051632) and Philips SMART Pads Il (#K072812). 6. Device Description These battery powered, automated… | 2000 |
| * | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870ASummary page 2…ional 510(k) PreMarket Notification Section IS, page 1 of 3 861388 and 861389 HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K 003565, #K 003819, #K014157 and #K051632) and Philips SMART Pads Il (#K072812). 6. Device Description These battery powered, automated external d… | 2001 |
| * | K014157 | HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841ASummary page 2…) PreMarket Notification Section IS, page 1 of 3 861388 and 861389 HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K 003565, #K 003819, #K014157 and #K051632) and Philips SMART Pads Il (#K072812). 6. Device Description These battery powered, automated external defibrillat… | 2002 |
| * | K051632 | Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A…Summary page 2…otification Section IS, page 1 of 3 861388 and 861389 HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K 003565, #K 003819, #K014157 and #K051632) and Philips SMART Pads Il (#K072812). 6. Device Description These battery powered, automated external defibrillators are avail… | 2005 |
| * | K072812 | Philips Heartstart Smartpads IiiSummary page 2…61388 and 861389 HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K 003565, #K 003819, #K014157 and #K051632) and Philips SMART Pads Il (#K072812). 6. Device Description These battery powered, automated external defibrillators are available in two models, one with ECG (mod… | 2008 |
What descends from it? (2)
2 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 6, 2014 | Class II | Z-1225-2014 | Process control | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K130684 (Philips Medical Systems, 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K003565.
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. 2011, this device’s year, is highlighted.
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 Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861388 and 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: Unresponsiveness Absence of normal breathing If in doubt, apply the pads. The Models 861388 and 861389 are…
Read the full statement (208 words)
The Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861388 and 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
Unresponsiveness
Absence of normal breathing
If in doubt, apply the pads.
The Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.
WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 Ibs (25 kg) or 8 years old.
The Models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) 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/K111693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111693: Philips Heartstart FR3 Automated External Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111693
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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