510(k) · Cleared
Recalled · Class II · 2020Lifepak 500 Automated External Defibrillator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Emergency Response Systems, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 17, 2006 as substantially equivalent to K955854 (Physio-Control Corp., 1996) and 4 other predicates after a 203-day review. Its family tree reaches back 6 generations to 1993. 1 of the 28 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 17, 2006
- Review
- 203 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 6 generations to K921669 (1993). 23 ancestors in all, the oldest K802288 (1980). 4 later devices descend from it, 2 citing it directly. 1 of the 28 devices in this family, counting this one, has 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 deviceK052057 Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK052465 Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and…Heartsine Technologies, Inc. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK142709 samaritan PAD 450PHeartsine Technologies, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK072596 Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc. · 2008
Class I recalls in this family
- K052465 Reduced Energy Pediatric Electrode Pads for the…cites it directly · 2006
Most influential descendants
Showing 4 of 4 · See all- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Heartsine Technologies, Inc. · 2006 · cites it directly2descendants
- K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · 2 generations on1descendant
- K142709samaritan PAD 450PHeartsine Technologies, Inc. · 2015 · 3 generations on0descendants
- K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc. · 2008 · cites it directly0descendants
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) | K052057 | Lifepak 500 Automated External Defibrillator | Medtronic Emergency Response Systems, Inc. | 2006 | — |
| +1 | K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models… | Heartsine Technologies, Inc. | 2006 | Class I |
| +2 | K123881 | Heartsine Samaritan Pad 350P | Heartsine Technologies, Inc. | 2013 | 1 |
| +3 | K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015 | — |
| +1 | K072596 | Life+Cel or Lifecel Battery Pack, Model 5L500 | Amco International Manufacturing & Design, Inc. | 2008 | — |
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 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K955854 | Lifepak 500Summary page 1…substantially equivalent to the previously cleared (09/28/01), 5 10(k) numbers K955854 (11/4/96), K983393 (05/05/99), K012428 Heartstart and K033275 (11/06/03); and the Philips Medical Systems… | 1996 |
| * | K983393 | Lifepak 500 BiphasicSummary page 1…ivalent to the previously cleared (09/28/01), 5 10(k) numbers K955854 (11/4/96), K983393 (05/05/99), K012428 Heartstart and K033275 (11/06/03); and the Philips Medical Systems Heartstream… | 1999 |
| * | K012428 | Modification to: Lifepak 500 Automated External DefibrillatorSummary page 1…ously cleared (09/28/01), 5 10(k) numbers K955854 (11/4/96), K983393 (05/05/99), K012428 Heartstart and K033275 (11/06/03); and the Philips Medical Systems Heartstream FR2+ AED, 510(k)… | 2001 |
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 1…(09/28/01), 5 10(k) numbers K955854 (11/4/96), K983393 (05/05/99), K012428 Heartstart and K033275 (11/06/03); and the Philips Medical Systems Heartstream FR2+ AED, 510(k) number K013425 (01/14/2002). Descriptio… | 2003 |
| * | K013425 | Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841ASummary page 1…96), K983393 (05/05/99), K012428 Heartstart and K033275 (11/06/03); and the Philips Medical Systems Heartstream FR2+ AED, 510(k) number K013425 (01/14/2002). Description: battery… | 2002 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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… |
| Jun 12, 2013 | Class II | Z-1773-2013 | Employee error | The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could… |
| Jun 6, 2011 | Not classified | Z-2885-2011 | Component design/selection | The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly. |
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.
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 23 ancestors have a recall of any class.
- Of its descendants, K052465 (Heartsine Technologies, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K955854.
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, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052057: Lifepak 500 Automated External Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052057
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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