510(k) · Cleared
Recalled · Class II · 2016Lifepak 12, 20, 500, CR Plus
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 Nov 6, 2003 as substantially equivalent to K991910 (Physio-Control Corp., 1999) and 5 other predicates after a 27-day review. Its family tree reaches back 5 generations to 1993. 4 of the 42 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2003
- Review
- 27 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to K921669 (1993). 21 ancestors in all, the oldest K802288 (1980). 20 later devices descend from it, 10 citing it directly. 4 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 4 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 3 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 2 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 1 generation backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- This deviceK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003
- 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
- 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- 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
- K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · cites it directly5descendants
- K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −4 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −3 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −2 | 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 |
| 0 (this device) | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | — |
| +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 |
| +1 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
| +2 | K103567 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991910 | Lifepak 12 BiphasicSummary page 1…d version of each device listed in the table below. Device 510(k) Information Medtronic Physio-Control LIFEPAK 12 K99 1910 (09/03/99) Defibrillator KO10918 (08/23/01) Medtronic Physio-Control LIFEPAK 20 KO122… | 1999 |
| * | K010918 | Lifepak 12 Defibrillator/Monitor System | 2001 |
| * | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | 2002 |
| * | K983393 | Lifepak 500 BiphasicSummary page 1…08/23/01) Medtronic Physio-Control LIFEPAK 20 KO12274 (02/05/02) I Defibrillator I I Medtronic Physio-Control LIFEPAK 500 I K983393 (05/05/99) AED KO 12428 (09/28/01) Medtronic Physio-Control LJFEPAK CR KO1 114… | 1999 |
| * | K012428 | Modification to: Lifepak 500 Automated External Defibrillator | 2001 |
| * | K011144 | Lifepak 600 Automated External Defibrillator | 2001 |
What descends from it? (20)
See all 2010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K052057 | Lifepak 500 Automated External Defibrillator | 2006 | 4 |
| K063119 | Lifepak 20 Defibrillator/ Monitor | 2006 | 2 |
| K073089 | Lifepak 20E | 2008 | 1 |
| K042404 | Lifepak, Model 1000 | 2005 | 1 |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor Class I | 2013 | 0 |
| K102972 | Lifepak 12 | 2010 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2016 | Class II | Z-2100-2016 | Component change control | LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently… |
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 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 2 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 · 2 generations on · ◆ in the 2006 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 10 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 21 ancestors have a recall of any class.
- Of its descendants, K040775 (Medtronic Physio-Control Corp., 2004) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K991910.
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. 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 and LIFEPAK 20 defibrillatodmonitors are not intended for use on pediatric patients less than 8 years old. The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be…
Read the full statement (194 words)
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. In AED mode, the LIFEPAK 12 and LIFEPAK 20 defibrillatodmonitors are not intended for use on pediatric patients less than 8 years old.
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).
The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus defibrillator may be used on children up to 8 years old of 25kg (55 Ib).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033275 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033275: Lifepak 12, 20, 500, CR Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033275
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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