510(k) · Cleared
Recalled · 2008Lifepak 12 Biphasic
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 Sep 3, 1999 as substantially equivalent to K973486 (Physio-Control Corp., 1998) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1993. 4 of the 38 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 3, 1999
- Review
- 88 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921669 (1993). 15 ancestors in all, the oldest K832833 (1984). 22 later devices descend from it, 8 citing it directly. 4 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 2 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 1 generation backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- This deviceK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999
- Descendant · cites it directly · 21 of its ownK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- Descendant · cites it directly · 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
- Descendant · cites it directly · 7 of its ownK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- 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 · cites it directly20descendants
- K040775Lifepak 12Medtronic Physio-Control Corp. · 2004 · cites it directly10descendants
- K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004 · cites it directly9descendants
- K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −2 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −1 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| 0 (this device) | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | — |
| +1 | 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 |
| +1 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K973486 | Life Pak 12Summary page 1…intended use and function of the Biphasic LIFEPAK 12 system are substantially equivalent to those of the: Physio-Control LIFEPAK 12 defibrillator/pacemaker, 510(k) no. K973486. Physio-Control LIFEPAK 500 automated external defibrillator, 510(K) no. K983393 Heartstream Forerunner defibrillator, 510(k) n… | 1998 |
| * | K983393 | Lifepak 500 BiphasicSummary page 1…ivalent to those of the: Physio-Control LIFEPAK 12 defibrillator/pacemaker, 510(k) no. K973486. Physio-Control LIFEPAK 500 automated external defibrillator, 510(K) no. K983393 Heartstream Forerunner defibrillator, 510(k) no. K955628. Mine Safety defibrillator, Preamendment. 08/19/99 13:… | 1999 |
| * | K955628 | Fore Runner External Defibrillator/Defibrillator PadsSummary page 1…illator/pacemaker, 510(k) no. K973486. Physio-Control LIFEPAK 500 automated external defibrillator, 510(K) no. K983393 Heartstream Forerunner defibrillator, 510(k) no. K955628. Mine Safety defibrillator, Preamendment. 08/19/99 13:48 FAX 425 867 4154 PHYSIO-CONTROL Corp. [d1o06 Descripti… | 1996 |
| * | — | Mine Safety defibrillator Named without a submission number |
What descends from it? (22)
See all 228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | 2002 | 21 |
| K033275 | Lifepak 12, 20, 500, CR Plus | 2003 | 20 |
| 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 |
| K062331 | Highpak-12 | 2007 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2008 | Not classified | Z-1858-2008 | Process control | The LIFEPAK12 defibrillator/monitor series (LP12) 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. |
| 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. |
| 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 · 3 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 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K012274 (Medtronic Physio-Control Corp., 2002) has gone furthest, with 21 descendants of its own.
- 7 other devices also cite its predicate K973486.
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?
Defibrillation therapy is used as a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. The AED 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.…
Read the full statement (183 words)
Defibrillation therapy is used as a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients.
The AED 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. The AED mode is not intended for use on children less than eight years of age, per AHA guidelines.
Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole.
The 3 and 4 wire ECG allows for identification or interpretation 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 of patients with acute myocardial infarction.
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO₂). 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/K991910 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991910: Lifepak 12 Biphasic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991910
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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