510(k) · Cleared
Recalled · 2011Life Pak 12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control Corp. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jan 9, 1998 as substantially equivalent to K951593 (Physio-Control Corp., 1995) and 4 other predicates after a 116-day review. Its family tree reaches back 2 generations to 1993. 4 of the 32 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 9, 1998
- Review
- 116 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 2 generations to K921669 (1993). 7 ancestors in all, the oldest K903644 (1991). 24 later devices descend from it, 8 citing it directly. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 1 generation backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- This deviceK973486 Life Pak 12Physio-Control Corp. · 1998
- Descendant · cites it directly · 22 of its ownK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- Descendant · cites it directly · 21 of its ownK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- Descendant · 2 generations on · 20 of its ownK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- Descendant · cites it directly · 10 of its ownK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- Descendant · cites it directly · 9 of its ownK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K991910Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · cites it directly22descendants
- K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · cites it directly21descendants
- K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · 2 generations on20descendants
- K040775Lifepak 12Medtronic Physio-Control Corp. · 2004 · cites it directly10descendants
- K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −1 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| 0 (this device) | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | — |
| +1 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| +1 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| +2 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| +1 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| +1 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 1 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 2 | 1 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 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.
4 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? (5)
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 |
|---|---|---|---|
| * | K951593 | Lifepak 11Summary page 1…ence: The intended use and function of the LIFEPAK 12 system are substantially equivalent to those of the Physio-Control LIFEPAK 11 defibrillator/pacemaker, 510(k) no. K951593. Physio-Control LIFEPAK 11 monitor, 510(k) no. K912189 e Hewlett Packard CodeMaster 100 defibrillator/monitor,… | 1995 |
| * | K912189 | Likepak 11 Cardiac Monit/Lifenet RS100 Rec StationSummary page 1…ystem are substantially equivalent to those of the Physio-Control LIFEPAK 11 defibrillator/pacemaker, 510(k) no. K951593. Physio-Control LIFEPAK 11 monitor, 510(k) no. K912189 e Hewlett Packard CodeMaster 100 defibrillator/monitor, 510(k) no. K950483 Marquette Electronics Responder 1500… | 1992 |
| * | K950483 | Hewlett Packard M2475B Codemaster 100 Defibrillator/MonitorSummary page 2…pacemaker, 510(k) no. K951593. Physio-Control LIFEPAK 11 monitor, 510(k) no. K912189 e Hewlett Packard CodeMaster 100 defibrillator/monitor, 510(k) no. K950483 Marquette Electronics Responder 1500 Defibrillator/Monitor, 510(k) no. K903644 Marquette Electronics Eagle 4000 monitor with 12… | 1995 |
| * | K903644 | Series 1500 12-Lead Analysis OptionSummary page 2…12189 e Hewlett Packard CodeMaster 100 defibrillator/monitor, 510(k) no. K950483 Marquette Electronics Responder 1500 Defibrillator/Monitor, 510(k) no. K903644 Marquette Electronics Eagle 4000 monitor with 12SL, 510(k) no. K964750 - Description: The LIFEPAK 12 defibrillator /monitor se… | 1991 |
| * | K964750 | Eagle 4000 Patient MonitorSummary page 2…nitor, 510(k) no. K950483 Marquette Electronics Responder 1500 Defibrillator/Monitor, 510(k) no. K903644 Marquette Electronics Eagle 4000 monitor with 12SL, 510(k) no. K964750 - Description: The LIFEPAK 12 defibrillator /monitor series is a complete acute cardiac response system - battery or auxiliary… | 1997 |
What descends from it? (24)
See all 248 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991910 | Lifepak 12 Biphasic | 1999 | 22 |
| K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | 2002 | 21 |
| K040775 | Lifepak 12 | 2004 | 10 |
| K041459 | Lifepak 12 Defibrillator/Monitor | 2004 | 9 |
| K063510 | Lifepak 12 Defibrillator/Monitor | 2007 | 7 |
| K082937 | Lifepak 15 Monitor/Defibrillator | 2009 | 5 |
| K102972 | Lifepak 12 | 2010 | 0 |
| K030898 | Mobile Battery Service Station (MBSS) | 2003 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2011 | Not classified | Z-2625-2011 | Device Design | The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications. |
| Feb 27, 2008 | Not classified | Z-1567-2008 | Labeling mix-ups | Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries. |
| Jan 27, 2003 | Not classified | Z-0542-03 | Other | Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit. |
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
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · 4 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K991910 (Physio-Control Corp., 1999) has gone furthest, with 22 descendants of its own.
- 1 other device also cites its predicate K951593.
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?
The AED mode is to be used only on patients in cardiopulmonary arrest. Thg patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. Defibrillation therapy is used as a means of terminating 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…
Read the full statement (175 words)
The AED mode is to be used only on patients in cardiopulmonary arrest. Thg patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
Defibrillation therapy is used as a means of terminating 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 supraventricular tachycardia, atrial fibrillation, atrial flutter, and, in relatively stable patients, ventricular tachycardia.
Noninvasive pacing is used as a means of treating symptématic bradycardia and asystole.
The 3 and 4 wire ECG allows for identification or interpetation of cardiac rhythms or dysrhythmias and calculation of heart rate.
The 12-lead electrocardiogram (ECG) is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment 6f patients with acute myocardial infarction.
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO,). It is used for monitoring patients who are at risk of developing hypoxemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973486: Life Pak 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973486
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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