510(k) · Cleared
ClearedLifepak 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 Mar 22, 2011 as substantially equivalent to K082937 (Physio-Control, Inc., 2009) after a 106-day review. Its family tree reaches back 10 generations to 1993. 2 of the 36 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Mar 22, 2011
- Review
- 106 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921669 (1993). 31 ancestors in all, the oldest K802288 (1980). 4 later devices descend from it, 2 citing it directly. 2 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations between
- 3 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- 2 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- 1 generation backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
- This deviceK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024
- Descendant · 3 generations on · 0 of its ownK253099 LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · Recalled (Class I)
Show all 10 generations
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 9 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 8 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 7 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 6 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 5 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 4 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- 3 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- 2 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- 1 generation backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
- This deviceK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · cites it directly2descendants
- K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024 · 2 generations on1descendant
- K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025 · 3 generations on0descendants
- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −9 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −8 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −7 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −6 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −5 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −4 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| −3 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| −2 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| −1 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
| 0 (this device) | K103567 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2011 | — |
| +1 | K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014 | Class I |
| +2 | K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control | 2024 | — |
| +3 | K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. | 2025 | — |
| +1 | K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor | Physio-Control, Inc. | 2013 | Class I |
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 |
|---|---|---|
| 2013 | 1 | 1 |
| 2014 | 1 | 1 |
| 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.
2 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? (1)
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 2…are substantially equivalent to the previously cleared LIFEPAK 15 monitor/defibrillator. The LIFEPAK 15 monitor/defibrillator was cleared under 510(k) number K082937 on 03111/09. Description: The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response syste… | 2009 |
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? (2 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.
- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 15 of the 31 ancestors have a recall of any class.
- Of its descendants, K142430 (Physio-Control, Inc., 2014) has gone furthest, with 2 descendants 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. 2011, 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 indioventricular 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 (STEMVI).
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SP02 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 perfusioh 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 C02 monitoring:
Indications
EtCO 2.monitoring is used to detect trends in the level of expired 002. 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 as stated in the FDA summary.
https://510kreport.com/device/K103567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103567: Lifepak 15 Monitor/Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103567
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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