510(k) · Cleared
Recalled · Class II · 2018Philips 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 18, 2013 as substantially equivalent to K111693 (Philips Medical Systems, 2011) and 4 other predicates after a 219-day review. Its family tree reaches back 4 generations to 2002. 1 of the 13 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Oct 18, 2013
- Review
- 219 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 4 generations to K020715 (2002). 12 ancestors in all, the oldest K003565 (2000). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK020715 Philips M5066A and M5068APhilips Medical Systems · 2002 · Recalled
- 3 generations backK050004 Philips Heartstart FRX Defibrillator, Model 861304Philips Medical Systems · 2005 · Recalled
- 2 generations backK072812 Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008
- 1 generation backK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · Recalled
- This deviceK130684 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013
Class I recalls in this family
- K051134 Heartstart MRX with Q-CPR Option, Models M3535A…direct predicate · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020715 | Philips M5066A and M5068A | Philips Medical Systems | 2002 | 12 |
| −3 | K050004 | Philips Heartstart FRX Defibrillator, Model 861304 | Philips Medical Systems | 2005 | 7 |
| −2 | K072812 | Philips Heartstart Smartpads Iii | Philips Medical Systems | 2008 | — |
| −1 | K111693 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2011 | 1 |
| 0 (this device) | K130684 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 1 |
| 2007 | 1 | 0 |
| 2012 | 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? (5)
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 |
|---|---|---|---|
| * | K111693 | Philips Heartstart FR3 Automated External DefibrillatorSummary page 4…the models 861389 and 861388 are unchanged in terms of specifications, nominal energy and peak current from those described in the previous submission, 510(k) #K 111693. The algorithm used to determine shock' recommendations and the SMART CPR algorithm that supports the CPR First functio… | 2011 |
| * | K013425 | Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A | 2002 |
| * | K014157 | HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841ASummary page 2…FR3"), 510(k) #Kl 111693 * Philips l-eartstream FR2+ with EGG Cable, 510(k) #KO 13425 * PhilIips Heartstreamn FR2+ with Rechargeable Battery, 510(k) #K014157 * Laerdal Medical CPRmeter CPR Feedback Device, 510(k) #K 122050 * HeartStart MPx monitor/defibrillator with… | 2002 |
| * | K122050 | Cprmeter CPR Feedback DeviceSummary page 2…ble, 510(k) #KO 13425 * PhilIips Heartstreamn FR2+ with Rechargeable Battery, 510(k) #K014157 * Laerdal Medical CPRmeter CPR Feedback Device, 510(k) #K 122050 * HeartStart MPx monitor/defibrillator with Q-CPR option, 510(k) #K05 1134 The design of the Philips Heartsta… | 2012 |
| * | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536ASummary page 2…y, 510(k) #K014157 * Laerdal Medical CPRmeter CPR Feedback Device, 510(k) #K 122050 * HeartStart MPx monitor/defibrillator with Q-CPR option, 510(k) #K05 1134 The design of the Philips Heartstart AED (FR3) Models 861388 and 861389 with the optional 3-Lead EGG Cable, op… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2018 | Class II | Z-0683-2018 | Device Design | Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC… |
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.
- K051134Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 9 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K111693.
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. 2013, 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 FR3 is 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 FR3 is 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 FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years…
Read the full statement (736 words)
The FR3 is 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 FR3 is 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 FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 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.
The FR3 is intended for use by responders who have been trained in its operation and qualified by training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physic ian-authorized emergency medical response program. The FR3 can be configured under the guidance of a Medical Director to enable Advanced Use mode and alternative cardiopulmonary resuscitation (CPR) protocols, such as CPR while Armed, CPR First-User, and CPR First-Always.
WARNING: Performance of the SMART CPR AUTO!I and AUTO2 settings for the CPR First feature has not been established in patients under 55 lb (25 kg) or 8 years old.
CPR Meter with Q-CPR
The FR3 can be used with the optional CPRI meter with Q-CPR® technology by Laerdal. The system is designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter.
WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lb (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled.
When attached to the bare chest of a suspected victim of SCA and connected to an 1113 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 alerts the responder when it detects hyperventilation (more than 12 ventilations per minute) of the patient during CPR.
3-Lead ECG Cable
In addition, at the discretion of a responder trained in its use, the optional FR3 3-Lead ECG Cable can be connected to the FR3 ECG model to provide a non-diagnostic EG display of the heart rhythm of a patient who is responsive and breathing normally but at risk of cardiac distress. The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. The responder can select display of lead vectors 1,11, or 111. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the FR3 continues to evaluate the patient's ECG. In addition, the 1113 alerts the responder to check the patient if the EGG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock. If the patient's rhythm or status changes, the responder can attend to the patient, as appropriate.
FR3 Rechargeable Battery
The FR3 rechargeable battery is intended for use by organizations, such as EMS or tire departments that use the FR3 frequently and want to decrease cost-per-use and reduce environmental waste. The rechargeable battery should only be used by organizations committed to providing the resources required to operate a battery maintenance program. Due to changes in the performance characteristics of rechargeable batteries over time, it is important for the battery maintenance program to monitor how many battery charge/discharge cycles the battery experiences, in order to determine when to retire it from service. The FR3 rechargeable battery is not recommended for infrequent-use environments such as office buildings, airlines, or public access defibrillation (PAD) programs. It should not be used as the spare or backup battery: instead, the standard primary battery should be used due to its long shelf-life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130684: 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/K130684
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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