510(k) · Cleared
Recalled · Class II · 2017Lifepak 12
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 22, 2010 as substantially equivalent to K063510 (Medtronic Emergency Response Systems, Inc., 2007) and 8 other predicates after a 77-day review. Its family tree reaches back 9 generations to 1993. It has been recalled once.
- Decided
- Dec 22, 2010
- Review
- 77 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 9 generations to K921669 (1993). 30 ancestors in all, the oldest K802288 (1980). No later device cites it as a predicate yet.
- 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 deviceK102972 Lifepak 12Physio-Control, Inc. · 2010
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 deviceK102972 Lifepak 12Physio-Control, Inc. · 2010
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) | K102972 | Lifepak 12 | Physio-Control, Inc. | 2010 | — |
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 |
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.
Planning a device in MKJ? 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…r/monitor. 51 0(k) numbers for the predicate LIFEPAK 12 defibrillator/monitor are listed below. 510(k) Number Clearance Date K063510 01/26/07 K041459 07/01/04 K040775 04/23/04… | 2007 |
| * | K041459 | Lifepak 12 Defibrillator/MonitorSummary page 2…LIFEPAK 12 defibrillator/monitor are listed below. 510(k) Number Clearance Date K063510 01/26/07 K041459 07/01/04 K040775 04/23/04 K033275 11/06/03… | 2004 |
| * | K040775 | Lifepak 12Summary page 2…. 510(k) Number Clearance Date K063510 01/26/07 K041459 07/01/04 K040775 04/23/04 K033275 11/06/03 K010918 03/26/0… | 2004 |
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 2…Date K063510 01/26/07 K041459 07/01/04 K040775 04/23/04 K033275 11/06/03 K010918 03/26/01 K002445 01/31/0… | 2003 |
| * | K010918 | Lifepak 12 Defibrillator/Monitor SystemSummary page 2…/07 K041459 07/01/04 K040775 04/23/04 K033275 11/06/03 K010918 03/26/01 K002445 01/31/01 K990338 09/01/9… | 2001 |
| * | K002445 | Lifepak 12DEFIBERLLATOR/Monitor SeriesSummary page 2…04 K040775 04/23/04 K033275 11/06/03 K010918 03/26/01 K002445 01/31/01 K990338 09/01/99 K(991910 06/03/9… | 2001 |
| * | K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemSummary page 2…04 K033275 11/06/03 K010918 03/26/01 K002445 01/31/01 K990338 09/01/99 K(991910 06/03/99 K973486 01/09/9… | 1999 |
| * | K991910 | Lifepak 12 BiphasicSummary page 2…K010918 03/26/01 K002445 01/31/01 K990338 09/01/99 K(991910 06/03/99 K973486 01/09/98 Description: The LIFEPAK 12 defibrillator/mo… | 1999 |
| * | K973486 | Life Pak 12Summary page 2…01 K002445 01/31/01 K990338 09/01/99 K(991910 06/03/99 K973486 01/09/98 Description: The LIFEPAK 12 defibrillator/monitor was designed for use in.a variety of h… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2017 | Class II | Z-1143-2017 | Process control | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 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.
- 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. 2010, 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 (385 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 CO2 monitoring:
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. 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/K102972 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102972: Lifepak 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102972
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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