510(k) · Cleared
Recalled · Class II · 2020Heartstart MRX, 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 Jan 11, 2007 as substantially equivalent to K031187 (Philips Medical Systems, 2003) and 2 other predicates after a 64-day review. Its family tree reaches back 2 generations to 2001. 3 of the 5 devices in its family, counting itself, have a Class I recall. It has been recalled 11 times.
- Decided
- Jan 11, 2007
- Review
- 64 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011865 (2001). 4 ancestors in all. No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK011865 Zoll M Series Ibp Operation; Zoll M Series Temperature OptionZoll Medical Corp · 2001
- 1 generation backK061707 Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · Recalled (Class I)
- This deviceK063375 Heartstart MRX, Models M3535A or M3536APhilips Medical Systems · 2007
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature Option | Zoll Medical Corp | 2001 | — |
| −1 | K061707 | Heartstart MRX, Invasive Pressure & Temperature Options | Philips Medical Systems | 2006 | Class I |
| 0 (this device) | K063375 | Heartstart MRX, Models M3535A or M3536A | Philips Medical Systems | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2005 | 1 | 1 |
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 1…Clinical Electronic Thermometer 3. The new device is substantially equivalent to the previously cleared HeartStart MRx Monitor/Defibrillator software cleared under K031187 and K051134, as well as K061707). 4. The modification is a change that provides an optional BluetoothTM wireless technology o… | 2003 |
| * | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536ASummary page 1…lectronic Thermometer 3. The new device is substantially equivalent to the previously cleared HeartStart MRx Monitor/Defibrillator software cleared under K031187 and K051134, as well as K061707). 4. The modification is a change that provides an optional BluetoothTM wireless technology option to tra… | 2005 |
| * | K061707 | Heartstart MRX, Invasive Pressure & Temperature OptionsSummary page 1…r 3. The new device is substantially equivalent to the previously cleared HeartStart MRx Monitor/Defibrillator software cleared under K031187 and K051134, as well as K061707). 4. The modification is a change that provides an optional BluetoothTM wireless technology option to transfer data from the… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2020 | Class II | Z-2064-2020 | Process control | Damaged ESD bags used for storing components in Processor PCA Replacement Kits |
| Feb 26, 2020 | Class II | Z-1499-2020 | Device Design | Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the… |
| Jan 14, 2020 | Class II | Z-1342-2020 | Process design | M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments |
| Jul 16, 2019 | Class II | Z-2488-2019 | Other | Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices. |
| Jun 7, 2019 | Class II | Z-1923-2019 | Process control | The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery… |
| May 3, 2018 | Class II | Z-2035-2018 | Employee error | The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed. |
| 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). |
| 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. |
| 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-0963-2015 | Software design | Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently. |
The 5 latest of 11 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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K031187.
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. 2007, 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 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 (333 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.
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 NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.
End-tidal C02
The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG
The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR
The Q-CPRT M 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/K063375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063375: Heartstart MRX, 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/K063375
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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