510(k) · Cleared
Recalled · Class I · 2019LIFEPAK 15 monitor/defibrillator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Dec 19, 2014 as substantially equivalent to K082937 (Physio-Control, Inc., 2009) and 1 other predicate after a 112-day review. Its family tree reaches back 11 generations to 1993. 1 of the 35 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 7 times, including 3 Class I recalls.
- Decided
- Dec 19, 2014
- Review
- 112 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 7 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 11 generations to K921669 (1993). 32 ancestors in all, the oldest K802288 (1980). 2 later devices descend from it, 1 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 7 generations between
- 3 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- 2 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
- 1 generation backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
- This deviceK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024
- Descendant · 2 generations on · 0 of its ownK253099 LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 10 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 9 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 8 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 7 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 6 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 5 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- 4 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- 3 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- 2 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
- 1 generation backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
- This deviceK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −10 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −9 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −8 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −7 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −6 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −5 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| −4 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| −3 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| −2 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
| −1 | K103567 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2011 | — |
| 0 (this device) | K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014 | — |
| +1 | K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control | 2024 | — |
| +2 | K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K082937 | Lifepak 15 Monitor/DefibrillatorSummary page 8…are below: Predicate Device 510(k) Number Clearance Date ® LIFEPAK 15 monitor/defibrillator K082937 March 11, 2009 ® LIFEPAK 15 monitor/defibrillator K103567 March 22,… | 2009 |
| * | K103567 | Lifepak 15 Monitor/DefibrillatorSummary page 8…® LIFEPAK 15 monitor/defibrillator K082937 March 11, 2009 ® LIFEPAK 15 monitor/defibrillator K103567 March 22, 2011 Description: The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | 2024 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2019 | Class II | Z-0816-2020 | Device Design | Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button. |
| Dec 20, 2019 | Class II | Z-0817-2020 | Device Design | Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button. |
| Feb 1, 2019 | Class I | Z-0863-2019 | Software design | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no… |
| Feb 1, 2019 | Class I | Z-0862-2019 | Software design | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no… |
| Jan 16, 2017 | Class II | Z-1144-2017 | Process control | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. |
| Jan 12, 2017 | Class I | Z-1123-2017 | Other | The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit… |
| Jan 27, 2016 | Class II | Z-1993-2016 | Software design | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 15 of the 32 ancestors have a recall of any class.
- Of its descendants, K240162 (Stryker Physio-Control, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K082937.
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. 2014, 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?
Manual Defibrillation: Indications Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Contraindications Defibrillation is…
Read the full statement (404 words)
Manual Defibrillation:
Indications
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications
Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO, monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.
End-Tidal CO2 monitoring:
Indications
EtCO, monitoring is used to detect trends in the level of expired CO,. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Invasive Pressure Monitoring:
Indications
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient’s condition or response to therapy. It may also be used to aid in medical diagnosis.
Temperature Monitoring:
Indications
Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142430: LIFEPAK 15 monitor/defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142430
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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