510(k) · Cleared
Recalled · Class I · 2020Heartstart MRX, Model M3535A
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 27, 2003 after a 134-day review. The FDA summary names its predicate without a number. 3 of the 45 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it. It has been recalled 21 times, including 2 Class I recalls.
- Decided
- Aug 27, 2003
- Review
- 134 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 21 (2 Class I)
- Predicates
- 0
44 later devices descend from it, 4 citing it directly. 3 of the 45 devices in this family, counting this one, have a Class I recall.
- This deviceK031187 Heartstart MRX, Model M3535APhilips Medical Systems · 2003
- Descendant · cites it directly · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · 5 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly37descendants
- K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
- K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants
- K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031187 | Heartstart MRX, Model M3535A | Philips Medical Systems | 2003 | — |
| +1 | K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +2 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| +3 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +4 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +5 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 2 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 (formally Agilent Technologies) Heartstream XL… Named without a submission number | |
| * | — | ZOLL Medical Corp. M Series Defibrillator Named without a submission number |
What descends from it? (44)
See all 444 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue… | 2010 | 37 |
| K061707 | Heartstart MRX, Invasive Pressure & Temperature Options Class I | 2006 | 4 |
| 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 |
|---|---|---|---|---|
| Sep 14, 2020 | Class II | Z-0284-2021 | Device Design | The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that… |
| Sep 14, 2020 | Class II | Z-0285-2021 | Device Design | The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that… |
| Jul 16, 2020 | Class II | Z-2794-2020 | Process control | The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock… |
| 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. |
| Jan 19, 2010 | Not classified | Z-1135-2010 | Nonconforming Material/Component | Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy |
| Aug 21, 2009 | Not classified | Z-0003-2010 | Process change control | incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power |
| Jul 7, 2009 | Not classified | Z-1795-2009 | Device Design | External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/CPR cable and the MRx/MRxE may wear at an increased rate ultimately prevent the device from sensing that the pads… |
| Jul 14, 2008 | Not classified | Z-2337-2008 | Nonconforming Material/Component | Defective internal memory cards may exhibit one or more of the following behaviors: "Device repeatedly restarts approximately every 20 seconds "Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays… |
| Apr 29, 2005 | Not classified | Z-0848-05 | Software design | The device may disarm and not deliver shock when performing a Synchronized Cardioversion |
| Dec 15, 2004 | Not classified | Z-0341-05 | Other | In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy |
The 5 latest of 21 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, K101600 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) has gone furthest, with 37 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 M R x 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. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillatorhlonitor has previously undergone…
Read the full statement (302 words)
The HeartStart M R x 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.
The SMART Biphasic waveform utilized in the Heartstream XL Defibrillatorhlonitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 15oJ. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications.
Manual Defibrillation: 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.
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.
Non-Invasive External Pacing:
The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
12-Lead ECG:
The 12-Lead ECG option is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms.
Non-Invasive Blood Pressure:
The NlBP option is intended for noninvasive measurement of arterial blood pressure for adult and pediatric patients.
Endtidal COz:
The EtC02 option is intended for noninvasive monitoring of exhaled carbon dioxide and to provide a respiration rate for adult, pediatric and neonatal patients.
Pulse Oximetry:
The SpOz option is intended for use when it is beneficial to assess the oxygen saturation level for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031187: Heartstart MRX, Model M3535A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031187
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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