510(k) · Cleared
Recalled · 2008Lifepak 20 Defibrillator/ Monitor
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 Dec 22, 2006 as substantially equivalent to K033275 (Medtronic Physio-Control Corp., 2003) and 1 other predicate after a 71-day review. Its family tree reaches back 6 generations to 1993. 1 of the 25 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 22, 2006
- Review
- 71 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921669 (1993). 22 ancestors in all, the oldest K802288 (1980). 2 later devices descend from it, 2 citing it directly. 1 of the 25 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 deviceK063119 Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK073089 Lifepak 20EPhysio-Control, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · Recalled (Class I)
Class I recalls in this family
- K130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E…cites it directly · 2013
Most influential descendants
Showing 2 of 2 · See allView 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) | K063119 | Lifepak 20 Defibrillator/ Monitor | Medtronic Emergency Response Systems, Inc. | 2006 | — |
| +1 | K073089 | Lifepak 20E | Physio-Control, Inc. | 2008 | 1 |
| +1 | K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor | Physio-Control, Inc. | 2013 | Class I |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 1 |
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? (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 |
|---|---|---|---|
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 2…res and functions of the modified LIFEPAK 20 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor (K033275, K012274). Description: The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for… | 2003 |
| * | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerSummary page 2…unctions of the modified LIFEPAK 20 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor (K033275, K012274). Description: The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "… | 2002 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| May 13, 2008 | Not classified | Z-2010-2008 | Device Design | A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual… |
| May 13, 2008 | Not classified | Z-2009-2008 | Device Design | A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode… |
| May 13, 2008 | Not classified | Z-2011-2008 | Device Design | A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual… |
| Apr 16, 2008 | Not classified | Z-1906-2008 | Software design | The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of… |
| Apr 16, 2008 | Not classified | Z-1905-2008 | Software design | The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly… |
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
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 10 of the 22 ancestors have a recall of any class.
- Of its descendants, K073089 (Physio-Control, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K033275.
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?
Manual Defibrillation: Indications: Defibrillation is a recognized means of terminating certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. The biphasic defibrillation waveform used in this device…
Read the full statement (199 words)
Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
The biphasic defibrillation waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063119: Lifepak 20 Defibrillator/ Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063119
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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