510(k) · Cleared
Recalled · 2010Lifepak 12 Defibrillator/Monitor System
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 Aug 23, 2001 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 23, 2001
- Review
- 149 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 4
- Predicates
- 0
21 later devices descend from it, 7 citing it directly. 4 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK010918 Lifepak 12 Defibrillator/Monitor SystemMedtronic Physio-Control Corp. · 2001
- 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
- Descendant · cites it directly · 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 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010918 | Lifepak 12 Defibrillator/Monitor System | Medtronic Physio-Control Corp. | 2001 | — |
| +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 |
| +1 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 217 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 |
|---|---|---|---|---|
| Oct 1, 2010 | Not classified | Z-1548-2011 | Device Design | L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after… |
| Mar 22, 2006 | Not classified | Z-0710-06 | Nonconforming Material/Component | Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. |
| Jul 12, 2005 | Not classified | Z-0004-06 | Process control | Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng… |
| 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?
- Of its descendants, K033275 (Medtronic Physio-Control Corp., 2003) has gone furthest, with 20 descendants of its own.
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 | — |
https://510kreport.com/device/K010918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010918: Lifepak 12 Defibrillator/Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010918
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026