510(k) · Cleared
Recalled · 2009Lifepak 12 Defibrillator/Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Emergency Response Systems, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jan 26, 2007 as substantially equivalent to K041459 (Medtronic Emergency Response Systems, Inc., 2004) and 7 other predicates after a 67-day review. Its family tree reaches back 8 generations to 1993. 2 of the 37 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 26, 2007
- Review
- 67 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 8
Its longest line of descent runs back 8 generations to K921669 (1993). 29 ancestors in all, the oldest K802288 (1980). 7 later devices descend from it, 2 citing it directly. 2 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 7 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 6 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 5 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 4 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 3 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 2 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- 1 generation backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- This deviceK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024
- Descendant · 4 generations on · 0 of its ownK253099 LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · cites it directly5descendants
- K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011 · 2 generations on4descendants
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 2 generations on2descendants
- K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024 · 3 generations on1descendant
- K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −7 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −6 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −5 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −4 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −3 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −2 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| −1 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| 0 (this device) | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | — |
| +1 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
| +2 | K103567 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2011 | — |
| +2 | K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014 | Class I |
| +3 | K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control | 2024 | — |
| +4 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (8)
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 |
|---|---|---|---|
| * | K041459 | Lifepak 12 Defibrillator/MonitorSummary page 2…res and functions of the modified LIFEPAK 12 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor… | 2004 |
| * | K040775 | Lifepak 12Summary page 2…unctions of the modified LIFEPAK 12 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was desi… | 2004 |
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 2…of the modified LIFEPAK 12 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was designed for… | 2003 |
| * | K010918 | Lifepak 12 Defibrillator/Monitor SystemSummary page 2…dified LIFEPAK 12 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was designed for use in a… | 2001 |
| * | K002445 | Lifepak 12DEFIBERLLATOR/Monitor SeriesSummary page 2…2 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of… | 2001 |
| * | K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemSummary page 2…defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital… | 1999 |
| * | K991910 | Lifepak 12 BiphasicSummary page 2…ator/monitor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-… | 1999 |
| * | K973486 | Life Pak 12Summary page 2…tor are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator/monitor (K041459, K040775, K033275, K010918, K002445, K990338, K991910, K973486). Description: The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital… | 1998 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2009 | Not classified | Z-0811-2010 | Nonconforming Material/Component | Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation… |
| Apr 16, 2008 | Not classified | Z-1904-2008 | Software design | The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of… |
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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 13 of the 29 ancestors have a recall of any class.
- Of its descendants, K082937 (Physio-Control, Inc., 2009) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K041459.
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. 2007, 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 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered 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…
Read the full statement (386 words)
Manual Defibrillation:
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered 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 12 defibrillator/monitor 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 myocardial infarction.
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring
Indications
Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.
End-Tidal C02 monitoring
Indications
EtCO 2 monitoring is indicated for detection of 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. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063510: Lifepak 12 Defibrillator/Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063510
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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