510(k) · Cleared
Recalled · Class II · 2020Modification to: Lifepak 500 Automated External Defibrillator
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 Sep 28, 2001 as substantially equivalent to K983393 (Physio-Control Corp., 1999) and 1 other predicate after a 59-day review. Its family tree reaches back 3 generations to 1995. 4 of the 29 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 28, 2001
- Review
- 59 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943301 (1995). 7 ancestors in all, the oldest K832833 (1984). 21 later devices descend from it, 2 citing it directly. 4 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK943301 Quik ComboPhysio-Control Corp. · 1995
- 2 generations backK955854 Lifepak 500Physio-Control Corp. · 1996 · Recalled
- 1 generation backK983393 Lifepak 500 BiphasicPhysio-Control Corp. · 1999 · Recalled
- This deviceK012428 Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001
- Descendant · cites it directly · 20 of its ownK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- Descendant · 2 generations on · 10 of its ownK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- Descendant · 2 generations on · 9 of its ownK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- Descendant · 2 generations on · 7 of its ownK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 5 of its ownK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · cites it directly20descendants
- K040775Lifepak 12Medtronic Physio-Control Corp. · 2004 · 2 generations on10descendants
- K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004 · 2 generations on9descendants
- K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · 2 generations on7descendants
- K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943301 | Quik Combo | Physio-Control Corp. | 1995 | — |
| −2 | K955854 | Lifepak 500 | Physio-Control Corp. | 1996 | 2 |
| −1 | K983393 | Lifepak 500 Biphasic | Physio-Control Corp. | 1999 | 1 |
| 0 (this device) | K012428 | Modification to: Lifepak 500 Automated External Defibrillator | Medtronic Physio-Control Corp. | 2001 | — |
| +1 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| +2 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| +2 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| +2 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| +2 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K983393 | Lifepak 500 BiphasicSummary page 1…tantial Equivalence: This defibrillator is substantially equivalent to the currently marketed Physio- Control LIF EPAK 500 automated external defibrillator, 510(k) nos. K983393 (Biphasic, cleared 6/6/99) and K955854 (Monophasic, cleared 11/4/96). Description and Reason for 510(k): The LIFEPAK 500 Automa… | 1999 |
| * | K955854 | Lifepak 500Summary page 1…r is substantially equivalent to the currently marketed Physio- Control LIF EPAK 500 automated external defibrillator, 510(k) nos. K983393 (Biphasic, cleared 6/6/99) and K955854 (Monophasic, cleared 11/4/96). Description and Reason for 510(k): The LIFEPAK 500 Automated External Defibrillator (AED) is a p… | 1996 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2020 | Class II | Z-1633-2020 | Device Design | Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which… |
| Apr 2, 2004 | Not classified | Z-0886-04 | Other | Potential for batteries to malfunction due to battery cell rupture. |
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
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K033275 (Medtronic Physio-Control Corp., 2003) has gone furthest, with 20 descendants of its own.
- 5 other devices also cite its predicate K983393.
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 LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally and showing no signs of circulation (for example, no pulse, no coughing, no movement) before the device is used to analyze the patient’s ECG rhythm. This device is not intended for use on children less than eight years of age, per AHA/ILCOR Guidelines.
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/K012428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012428: Modification to: Lifepak 500 Automated External Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012428
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026