510(k) · Cleared
Recalled · Class I · 2017Heartstart MRX, Invasive Pressure & Temperature Options
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 Aug 11, 2006 as substantially equivalent to K031187 (Philips Medical Systems, 2003) and 2 other predicates after a 56-day review. Its family tree reaches back 1 generation to 2001. 3 of the 8 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 12 times, including 2 Class I recalls.
- Decided
- Aug 11, 2006
- Review
- 56 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 12 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 1 generation to K011865 (2001). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly. 3 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK011865 Zoll M Series Ibp Operation; Zoll M Series Temperature OptionZoll Medical Corp · 2001
- This deviceK061707 Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006
- Descendant · cites it directly · 2 of its ownK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
- Descendant · 2 generations on · 1 of its ownK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
- Descendant · 3 generations on · 0 of its ownK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK063375 Heartstart MRX, Models M3535A or M3536APhilips Medical Systems · 2007 · Recalled
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013 · cites it directly2descendants
- K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems · 2015 · 2 generations on1descendant
- K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · 3 generations on0descendants
- K063375Heartstart MRX, Models M3535A or M3536APhilips Medical Systems · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature Option | Zoll Medical Corp | 2001 | — |
| 0 (this device) | K061707 | Heartstart MRX, Invasive Pressure & Temperature Options | Philips Medical Systems | 2006 | — |
| +1 | K130153 | Hearstart MRX with Airway Confimration Assist | Philips Medical Systems | 2013 | — |
| +2 | K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring | Philips Medical Systems | 2015 | — |
| +3 | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | 4 |
| +1 | K063375 | Heartstart MRX, Models M3535A or M3536A | Philips Medical Systems | 2007 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2005 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K031187 | Heartstart MRX, Model M3535ASummary page 2…aims equivalence for the HeartStart MRx Invasive Pressure Option and Temperature Option are as follows: * Philips Medical Systems HeartStart MRx Monitor/Defibrillator K031187, K051134, and * ZOLL Medical Corp. M Series IBP Option and Temperature Option KO11865 The design of the HeartStart MRx is subs… | 2003 |
| * | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536ASummary page 2…valence for the HeartStart MRx Invasive Pressure Option and Temperature Option are as follows: * Philips Medical Systems HeartStart MRx Monitor/Defibrillator K031187, K051134, and * ZOLL Medical Corp. M Series IBP Option and Temperature Option KO11865 The design of the HeartStart MRx is substantially… | 2005 |
| * | K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature Option | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
The 5 latest of 12 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.
- 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
- K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
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 MRx 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…
Read the full statement (330 words)
The HeartStart MRx 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
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.
Noninvasive 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.
Noninvasive Blood Pressure Monitoring
The NBP option is intended for noninvasive measurement of a patient's arterial blood pressure.
End-tidal C02
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 function isto provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR
The Q-CPR TM 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 that 25 kg).
The Q-CPR option is not for use when CPR is contraindicated.
Invasive Pressure
The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.
Temperature
The Temperature option is indicated for measuring temperature in patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061707: Heartstart MRX, Invasive Pressure & Temperature Options.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061707
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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