510(k) · Cleared
Recalled · Class I · 2020Heartstart MRX with Q-CPR Option, Models M3535A or M3536A
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 Sep 8, 2005 after a 128-day review. The FDA summary names its predicate without a number. 3 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 39 times, including 2 Class I recalls.
- Decided
- Sep 8, 2005
- Review
- 128 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 39 (2 Class I)
- Predicates
- 0
13 later devices descend from it, 6 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK051134 Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005
- Descendant · cites it directly · 5 of its ownK122050 Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012
- Descendant · cites it directly · 4 of its ownK061707 Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK151702 Reusable Full Silicone CoverLaerdal Medical AS · 2015
- Descendant · 3 generations on · 2 of its ownK173886 CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018
- Descendant · 2 generations on · 2 of its ownK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K122050Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012 · cites it directly5descendants
- K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · cites it directly4descendants
- K151702Reusable Full Silicone CoverLaerdal Medical AS · 2015 · 2 generations on3descendants
- K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018 · 3 generations on2descendants
- K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536A | Philips Medical Systems | 2005 | — |
| +1 | K122050 | Cprmeter CPR Feedback Device | Laerdal Medical A/S | 2012 | — |
| +1 | K061707 | Heartstart MRX, Invasive Pressure & Temperature Options | Philips Medical Systems | 2006 | Class I |
| +2 | K151702 | Reusable Full Silicone Cover | Laerdal Medical AS | 2015 | — |
| +3 | K173886 | CPRmeter 2 CPR Feedback Device | Laerdal Medical AS | 2018 | — |
| +2 | K130153 | Hearstart MRX with Airway Confimration Assist | Philips Medical Systems | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 2 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
3 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? (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 |
|---|---|---|---|
| * | — | Philips Medical Systems HeartStart MRx monitor/defibrillator Named without a submission number | |
| * | — | ZOLL Medical Corp. Zoll AED Plus with CPR-D Padz external defibrillator Named without a submission number |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122050 | Cprmeter CPR Feedback Device | 2012 | 5 |
| K061707 | Heartstart MRX, Invasive Pressure & Temperature Options Class I | 2006 | 4 |
| K130684 | Philips Heartstart FR3 Automated External Defibrillator | 2013 | 0 |
| K123597 | Truecpr Coaching Device | 2013 | 0 |
| K063375 | Heartstart MRX, Models M3535A or M3536A | 2007 | 0 |
| K062233 | Heartstart MRX Monitor/Defibrillator Class I | 2006 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2020 | Class II | Z-2157-2020 | Process change control | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections |
| Nov 23, 2018 | Class II | Z-0603-2019 | Nonconforming Material/Component | Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the… |
| Jan 29, 2018 | Class II | Z-0684-2018 | 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… |
| Sep 28, 2017 | Class II | Z-0278-2018 | Nonconforming Material/Component | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram). |
| Jul 17, 2017 | Class II | Z-0348-2018 | Device Design | Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference… |
| Jul 12, 2017 | Class I | Z-0489-2018 | Nonconforming Material/Component | Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode. |
| Feb 24, 2017 | Class I | Z-1417-2017 | Device Design | HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring |
| Aug 26, 2016 | Class II | Z-2842-2016 | Device Design | The handle can separate from the MRx housing due to breakage of mounts on the rear case. |
| Apr 14, 2016 | Class II | Z-1612-2016 | Employee error | MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. |
| Oct 14, 2015 | Class II | Z-0320-2016 | Software design | The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when… |
| Dec 23, 2014 | Class II | Z-0219-2016 | Software design | MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed |
| Nov 19, 2014 | Class II | Z-0204-2016 | Process control | 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a… |
| Nov 19, 2014 | Class II | Z-0273-2016 | Device Design | When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while… |
| Nov 19, 2014 | Class II | Z-0262-2016 | Device Design | MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle… |
| Nov 19, 2014 | Class II | Z-0963-2015 | Software design | Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently. |
| Feb 18, 2014 | Class II | Z-1108-2014 | Software design | Wireless Link may be unable to transmit data when configured for a specific data flow. |
| Feb 18, 2014 | Class II | Z-1120-2014 | Device Design | Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source |
| Feb 18, 2014 | Class II | Z-1090-2014 | Device Design | A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform. |
| Feb 18, 2014 | Class II | Z-1118-2014 | Component design/selection | ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal |
| Feb 18, 2014 | Class II | Z-1194-2014 | Software Design Change | When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon. |
| Feb 14, 2014 | Class II | Z-1109-2014 | Component design/selection | Philips HeartStart XL may experience a power board failure causing failure to defibrillate |
| Feb 4, 2014 | Class II | Z-1110-2014 | Device Design | HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers |
| Dec 10, 2013 | Class II | Z-0570-2014 | Software design | MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg |
| Jun 19, 2013 | Class II | Z-1797-2013 | Software design | The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation. |
| Jun 7, 2013 | Class II | Z-0593-2014 | Labeling Change Control | Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10 |
| Apr 10, 2013 | Class II | Z-0613-2014 | Environmental control | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and |
| Apr 8, 2013 | Class II | Z-1189-2013 | Software design | Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. |
| Jun 20, 2012 | Class II | Z-1896-2012 | Process control | HeartStart MRx Unexpected Pads/Paddles ECG Failure |
| Jun 20, 2012 | Class II | Z-1986-2012 | Nonconforming Material/Component | Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG |
| Jun 20, 2012 | Class II | Z-2347-2012 | Equipment maintenance | Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables |
| Feb 7, 2011 | Not classified | Z-1609-2011 | Software design | Software: EtCO2 and Ventilation Rate values may be labeled incorrectly. |
| May 6, 2010 | Not classified | Z-2293-2010 | Device Design | Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplete release of chest compression, which… |
| Apr 7, 2010 | Not classified | Z-1618-2010 | Component design/selection | ECG signal processing chip may fail causing failure to deliver therapy in AED mode or the failure to indicate poor electrical contact (very high impedance) with the patient in Manual Defib mode. |
| Mar 4, 2010 | Not classified | Z-1317-2010 | Component design/selection | Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery. |
| Nov 19, 2009 | Not classified | Z-1260-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1259-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1257-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1258-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 12, 2009 | Not classified | Z-0562-2010 | Device Design | HeartStart Vehicle Wall Mount (Model M5528A) with DC Power Module (Model M5529A)--Incorrect wiring during installation by user may result in a smoke or fire hazard. |
The 5 latest of 39 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.
- K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
- K062233Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K122050 (Laerdal Medical A/S, 2012) has gone furthest, with 5 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 HeartStart MRx monitor/defibrillator with Q-CPR™ option is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. AED Therapy To be used in the presence of a suspected cardiac arrest on…
Read the full statement (309 words)
The HeartStart MRx monitor/defibrillator with Q-CPR™ option is for use for the termination of ventricular tachycardia and ventricular fibrillation.
The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
AED Therapy
To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation Therapy
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized defibrillation is indicated for termination of atrial fibrillation.
Non-Invasive External Pacing Therapy
The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
Pulse Oximetry
The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.
Non-Invasive Blood Pressure Monitoring
The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure.
Endtidal CO2 Monitoring
The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG
The 12-Lead ECG option is intended to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR
The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time).
The Q-CPR option is contraindicated as follows:
* The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg).
* The Q-CPR option is not for use when CPR is contraindicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051134: Heartstart MRX with Q-CPR Option, Models M3535A or M3536A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051134
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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