510(k) · Cleared
ClearedHeartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring
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 23, 2015 as substantially equivalent to K110825 (Philips Medical Systems, 2012) and 3 other predicates after a 422-day review. Its family tree reaches back 12 generations to 1997. 5 of the 59 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 23, 2015
- Review
- 422 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K962603 (1997). 57 ancestors in all, the oldest K893221 (1990). 1 later device descends from it, 1 citing it directly. 5 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations between
- 3 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 2 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 1 generation backK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
- This deviceK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
- Descendant · cites it directly · 0 of its ownK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · Recalled
Show all 12 generations
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 10 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 9 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 8 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 7 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 6 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 5 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 4 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 3 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 2 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 1 generation backK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
- This deviceK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −11 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −10 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −9 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −8 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −7 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −6 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −5 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −4 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −3 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −2 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −1 | K130153 | Hearstart MRX with Airway Confimration Assist | Philips Medical Systems | 2013 | — |
| 0 (this device) | K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring | Philips Medical Systems | 2015 | — |
| +1 | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 1 |
| 2003 | 3 | 1 |
| 2004 | 2 | 0 |
| 2005 | 3 | 1 |
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
5 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? (4)
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 |
|---|---|---|---|
| * | K110825 | Philips Heartstart XL+, Philips Heartstart External Paddles, Philips Multifunction…Summary page 4….5310 Regulation: Device Class: Class III Product Code: MKJ, LDD, DRO, MHX, DXN, CCK, DQA Predicate Device: PhilipsHeartStart XL+ Defibrillator Monitor (K110825) Philips HeartStart MRx Defibrillator/Monitor (K130153) Zoll E Series Defibrillator/Monit… | 2012 |
| * | K130153 | Hearstart MRX with Airway Confimration AssistSummary page 4…LDD, DRO, MHX, DXN, CCK, DQA Predicate Device: PhilipsHeartStart XL+ Defibrillator Monitor (K110825) Philips HeartStart MRx Defibrillator/Monitor (K130153) Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903)… | 2013 |
| * | K080903 | Zoll E Series with Intibation Assist OptionSummary page 4…Philips HeartStart MRx Defibrillator/Monitor (K130153) Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903) Zoll R Series with NIBPand ETCO2 Option (K090989) Device The Philips HeartStart XL+ with End-T… | 2008 |
| * | K090989 | Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesSummary page 4…Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903) Zoll R Series with NIBPand ETCO2 Option (K090989) Device The Philips HeartStart XL+ with End-Tidal Carbon Dioxide Description: Monitoring Defibrillator/Monit… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200849 | Tempus LS - Manual | 2020 | 0 |
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 12 Class I recalls
- K051134Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
- K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 57 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K200849 (Remote Diagnostic Technologies, Ltd. A Philips Company, 2020) has gone furthest, with 0 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. 2015, 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 XL+ is a defibrillator/monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician. AED Therapy: AED mode is used in the presence of suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless. Manual Defribillation: Asynchronous…
Read the full statement (198 words)
The HeartStart XL+ is a defibrillator/monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.
AED Therapy: AED mode is used in the presence of suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Manual Defribillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation (cardioversion) is indicated for termination of certain atrial and ventricular arrhythmias.
Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia.
Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient’s oxygen saturation level.
Non-Invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive measurement of a patient’s arterial blood pressure.
End-Tidal CO2: The EtCO2 option is intended for noninvasive monitoring of a patient’s exhaled carbon dioxide and to provide a respiration rate.
ECG Monitoring: ECG monitoring is indicated to be used for monitoring, alarming and recording of the patient’s heart rate and morphology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133659
Report an extraction error
Are you the manufacturer?
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