510(k) · Cleared
Recalled · Class II · 2010Lifepak 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 11, 2009 as substantially equivalent to K063510 (Medtronic Emergency Response Systems, Inc., 2007) and 8 other predicates after a 161-day review. Its family tree reaches back 9 generations to 1993. 2 of the 36 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 11, 2009
- Review
- 161 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 3
- Predicates
- 9
Its longest line of descent runs back 9 generations to K921669 (1993). 30 ancestors in all, the oldest K802288 (1980). 5 later devices descend from it, 3 citing it directly. 2 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations between
- 3 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- 2 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- 1 generation backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- This deviceK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK103567 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 9 generations
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 8 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 7 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 6 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 5 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 4 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 3 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- 2 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- 1 generation backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- This deviceK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| −9 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −8 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −7 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −6 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −5 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −4 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −3 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| −2 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| −1 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| 0 (this device) | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | — |
| +1 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (9)
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 |
|---|---|---|---|
| * | K063510 | Lifepak 12 Defibrillator/MonitorSummary page 2…dates. Table 1 510(k) Number Clearance Date K063510 01/26/07 K041459 07/01/0… | 2007 |
| * | K041459 | Lifepak 12 Defibrillator/MonitorSummary page 2…Clearance Date K063510 01/26/07 K041459 07/01/04 K040775 04/23/0… | 2004 |
| * | K040775 | Lifepak 12Summary page 2…01/26/07 K041459 07/01/04 K040775 04/23/04 K033275 11/06/0… | 2004 |
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 2…07/01/04 K040775 04/23/04 K033275 11/06/03 K010918 03/26/0… | 2003 |
| * | K010918 | Lifepak 12 Defibrillator/Monitor SystemSummary page 2…04/23/04 K033275 11/06/03 K010918 03/26/01 K002445 01/31/0… | 2001 |
| * | K002445 | Lifepak 12DEFIBERLLATOR/Monitor SeriesSummary page 2…11/06/03 K010918 03/26/01 K002445 01/31/01 K990338 09/01/9… | 2001 |
| * | K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemSummary page 2…03/26/01 K002445 01/31/01 K990338 09/01/99 K991910 06/03/9… | 1999 |
| * | K991910 | Lifepak 12 BiphasicSummary page 2…01/31/01 K990338 09/01/99 K991910 06/03/99 K973486 01/09/9… | 1999 |
| * | K973486 | Life Pak 12Summary page 2…09/01/99 K991910 06/03/99 K973486 01/09/98 Performance This 510(k) includes documentation related to the verification… | 1998 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2010 | Class II | Z-0761-2017 | Environmental control | Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power… |
| Mar 4, 2010 | Not classified | Z-1410-2010 | Device Design | Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off. |
| Aug 12, 2009 | Not classified | Z-2110-2009 | Software design | Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in… |
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 16 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 30 ancestors have a recall of any class.
- Of its descendants, K103567 (Physio-Control, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K063510.
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. 2009, 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 (387 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 eight 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. 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 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 C02 monitoring
Indications
EtCO 2 monitoring is used to detect trends in the level of expired C02. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082937: 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/K082937
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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