510(k) · Cleared
Recalled · 2005Lifepak 12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Physio-Control Corp. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Apr 23, 2004 as substantially equivalent to K033275 (Medtronic Physio-Control Corp., 2003) and 5 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1993. 2 of the 38 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 2004
- Review
- 28 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K921669 (1993). 27 ancestors in all, the oldest K802288 (1980). 10 later devices descend from it, 5 citing it directly. 2 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 4 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 3 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 2 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 1 generation backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- This deviceK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004
- Descendant · cites it directly · 9 of its ownK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- 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)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004 · cites it directly9descendants
- K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −5 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −4 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −3 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −2 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −1 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| 0 (this device) | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | — |
| +1 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| +1 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| +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 |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 1…d functions of the modified LIFEPAK® 12 defibrillator are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Descr… | 2003 |
| * | K010918 | Lifepak 12 Defibrillator/Monitor SystemSummary page 1…odified LIFEPAK® 12 defibrillator are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Description:… | 2001 |
| * | K002445 | Lifepak 12DEFIBERLLATOR/Monitor SeriesSummary page 1…defibrillator are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Description: The LIFEPAK® 12 defi… | 2001 |
| * | K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemSummary page 1…bstantially equivalent to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Description: The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is… | 1999 |
| * | K991910 | Lifepak 12 BiphasicSummary page 1…nt to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Description: The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute… | 1999 |
| * | K973486 | Life Pak 12Summary page 1…cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98). Description: The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute cardiac res… | 1998 |
What descends from it? (10)
5 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 |
|---|---|---|---|---|
| Jan 15, 2005 | Not classified | Z-0495-05 | Software design | The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so. |
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 11 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 27 ancestors have a recall of any class.
- Of its descendants, K041459 (Medtronic Emergency Response Systems, Inc., 2004) has gone furthest, with 9 descendants of its own.
- 9 other devices also cite its predicate K033275.
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.
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?
AEF) mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless. and not breathing spontaneously 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. Manual D)elibrillation is indicated for the termination of certain potentially fat3al arrhythmias, such as ventricular…
Read the full statement (293 words)
AEF) mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless. and not breathing spontaneously 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.
Manual D)elibrillation is indicated for the termination of certain potentially fat3al arrhythmias, such as ventricular fibrillation and symptornatic 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.
Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.
12-Lead ElectrocardiopraphN, Y is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oxinmetry is used ito check the saturation of oxygen in arterial blood. It is indicated for use in any p:1iient who is ai risk of developing hypoxemia.
Noninvasive Blood Pressure MonitorinLt 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 is indicated for detection of trends in the level of expired C02. It is used for monitoring breathing efficacy 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 is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040775 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040775: 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/K040775
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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