510(k) · Cleared
Recalled · 2010Lifepak 20E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jul 29, 2008 as substantially equivalent to K063119 (Medtronic Emergency Response Systems, Inc., 2006) and 2 other predicates after a 271-day review. Its family tree reaches back 7 generations to 1993. 1 of the 25 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 29, 2008
- Review
- 271 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K921669 (1993). 23 ancestors in all, the oldest K802288 (1980). 1 later device descends from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 5 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 4 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 3 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 2 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 1 generation backK063119 Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc. · 2006 · Recalled
- This deviceK073089 Lifepak 20EPhysio-Control, Inc. · 2008
- 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 1 of 1 · See all- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −6 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −5 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −4 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −3 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −2 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −1 | K063119 | Lifepak 20 Defibrillator/ Monitor | Medtronic Emergency Response Systems, Inc. | 2006 | 5 |
| 0 (this device) | K073089 | Lifepak 20E | Physio-Control, Inc. | 2008 | — |
| +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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K063119 | Lifepak 20 Defibrillator/ MonitorSummary page 2…The features and functions of the LIFEPAK 20e defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor (K063119, K033275, and K012274). Description: The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and… | 2006 |
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 2…ures and functions of the LIFEPAK 20e defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor (K063119, K033275, and K012274). Description: The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics f… | 2003 |
| * | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerSummary page 2…tions of the LIFEPAK 20e defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor (K063119, K033275, and K012274). Description: The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "cr… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor Class I | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2010 | Not classified | Z-1722-2011 | Device Design | A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted. |
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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 23 ancestors have a recall of any class.
- Of its descendants, K130454 (Physio-Control, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K063119.
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. 2008, this device’s year, is highlighted.
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 20e 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/K073089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073089: Lifepak 20E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073089
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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