510(k) Report

510(k) · Cleared

Recalled · Class I · 2017

Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor

K130454510(k) TraditionalCleared Aug 21, 2013180-day reviewClass III21 CFR 870.5310Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Physio-Control, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Aug 21, 2013 as substantially equivalent to K012274 (Medtronic Physio-Control Corp., 2002) and 5 other predicates after a 180-day review. Its family tree reaches back 11 generations to 1993. 1 of the 35 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
Aug 21, 2013
Review
180 days
Class
Class III
Product code
MKJ
Recalls
1 (1 Class I)
Predicates
6

Its longest line of descent runs back 11 generations to K921669 (1993). 34 ancestors in all, the oldest K802288 (1980). No later device cites it as a predicate yet. 1 of the 35 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2008: 1 other ancestor2006: 1 other ancestor2001: 4 other ancestors1999: 2 other ancestors1980: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1995: 4 other ancestors1992: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1984: 1 other ancestor1994: 1 other ancestorK921669 · Marquette SL Series Transport Remote Acquisition · Marquette Electronics, Inc. · 1993K964750 · Eagle 4000 Patient Monitor · Marquette Electronics, Inc. · 1997K973486 · Life Pak 12 · Physio-Control Corp. · 1998 · recalledK991910 · Lifepak 12 Biphasic · Physio-Control Corp. · 1999 · recalledK012274 · Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker · Medtronic Physio-Control Corp. · 2002 · recalledK033275 · Lifepak 12, 20, 500, CR Plus · Medtronic Physio-Control Corp. · 2003 · recalled×2: 2 generations cleared close together, K040775 (2004), K041459 (2004) K063510 · Lifepak 12 Defibrillator/Monitor · Medtronic Emergency Response Systems, Inc. · 2007 · recalledK082937 · Lifepak 15 Monitor/Defibrillator · Physio-Control, Inc. · 2009 · recalledK103567 · Lifepak 15 Monitor/Defibrillator · Physio-Control, Inc. · 201119801985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 11 other ancestors4 generations back: 3 other ancestors K103567 · Lifepak 15 Monitor/Defibrillator · Physio-Control, Inc. · 2011K082937 · Lifepak 15 Monitor/Defibrillator · Physio-Control, Inc. · 2009 · recalledK063510 · Lifepak 12 Defibrillator/Monitor · Medtronic Emergency Response Systems, Inc. · 2007 · recalledK041459 · Lifepak 12 Defibrillator/Monitor · Medtronic Emergency Response Systems, Inc. · 2004K040775 · Lifepak 12 · Medtronic Physio-Control Corp. · 2004 · recalledK033275 · Lifepak 12, 20, 500, CR Plus · Medtronic Physio-Control Corp. · 2003 · recalledK012274 · Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker · Medtronic Physio-Control Corp. · 2002 · recalledK991910 · Lifepak 12 Biphasic · Physio-Control Corp. · 1999 · recalledK973486 · Life Pak 12 · Physio-Control Corp. · 1998 · recalledK964750 · Eagle 4000 Patient Monitor · Marquette Electronics, Inc. · 1997K921669 · Marquette SL Series Transport Remote Acquisition · Marquette Electronics, Inc. · 1993−10−50
  1. Root · 11 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 7 generations between
  3. 3 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
  4. 2 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
  5. 1 generation backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
  6. This deviceK130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013
Show all 11 generations
  1. Root · 11 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 10 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
  3. 9 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
  4. 8 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
  5. 7 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
  6. 6 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
  7. 5 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
  8. 4 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
  9. 3 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
  10. 2 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
  11. 1 generation backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
  12. This deviceK130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K921669Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc.1993—
−10K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc.1997—
−9K973486Life Pak 12Physio-Control Corp.19983
−8K991910Lifepak 12 BiphasicPhysio-Control Corp.19993
−7K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.200217
−6K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp.20031
−5K040775Lifepak 12Medtronic Physio-Control Corp.20041
−4K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.2004—
−3K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20072
−2K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20093
−1K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.2011—
0 (this device)K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198410
199010
199110
199220
199410
199540
199620
199820
199920
200140
200610
200810
FIG. 1 — Lineage of K130454, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.200217
*K033275Lifepak 12, 20, 500, CR Plus
Summary page 2
…nce numbers for the predicate devices are below: Predicate Device 510(k) Number(s) LIFEPAK® 20 dlefibrillator/monitor K0l 2274, K033275, K063119 LIFEPAK® 20e defibrillator/monitor K073089 LIFIEPAK® 15…
Medtronic Physio-Control Corp.20031
*K063119Lifepak 20 Defibrillator/ Monitor
Summary page 2
…Predicate Device 510(k) Number(s) LIFEPAK® 20 dlefibrillator/monitor K0l 2274, K033275, K063119 LIFEPAK® 20e defibrillator/monitor K073089 LIFIEPAK® 15 monitor/dlefibrillator K082937, K103567 Description…
Medtronic Emergency Response Systems, Inc.20065
*K073089Lifepak 20E
Summary page 2
…(s) LIFEPAK® 20 dlefibrillator/monitor K0l 2274, K033275, K063119 LIFEPAK® 20e defibrillator/monitor K073089 LIFIEPAK® 15 monitor/dlefibrillator K082937, K103567 Description: The LIFEPAK 20 and LIFIEPAK 20e dlefibrillato…
Physio-Control, Inc.20081
*K082937Lifepak 15 Monitor/Defibrillator
Summary page 2
…2274, K033275, K063119 LIFEPAK® 20e defibrillator/monitor K073089 LIFIEPAK® 15 monitor/dlefibrillator K082937, K103567 Description: The LIFEPAK 20 and LIFIEPAK 20e dlefibrillator/monitors were designed especially for hospital…
Physio-Control, Inc.20093
*K103567Lifepak 15 Monitor/Defibrillator
Summary page 2
…33275, K063119 LIFEPAK® 20e defibrillator/monitor K073089 LIFIEPAK® 15 monitor/dlefibrillator K082937, K103567 Description: The LIFEPAK 20 and LIFIEPAK 20e dlefibrillator/monitors were designed especially for hospitals and cli…
Physio-Control, Inc.2011—

Also cleared against K012274: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 4, 2017Class IZ-0294-2018OtherPhysio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • 17 of the 34 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K012274.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · MKJ

48in 2025

2007: 72008: 132009: 82010: 42011: 112012: 102013: 72014: 112015: 62017: 42018: 202019: 252020: 522021: 412022: 192023: 242024: 272025: 482026 (partial year): 31
2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007: 69 days median2008: 141 days median2009: 165 days median2010: 250 days median2011: 36 days median2012: 197 days median2013: 191 days median2014: 196 days median2015: 156 days median
2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007: 122008: 242009: 372010: 352011: 72012: 5, 1 Class I2013: 42014: 24, 15 Class I2015: 12016: 2, 1 Class I2017: 6, 4 Class I2018: 32019: 6, 2 Class I2020: 22021: 42022: 32023: 112024: 52025: 12026 (partial year): 3
2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007: 3,9582008: 4,7522009: 6,7822010: 7,3992011: 8,1702012: 9,7322013: 14,9552014: 15,3992015: 16,1292016: 17,0622017: 16,6842018: 16,5912019: 16,8612020: 16,1972021: 16,3002022: 14,8672023: 13,7662024: 15,1092025: 13,315
2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007769123,958
200813141244,752
20098165376,782
20104250357,399
2011113678,170
2012101975 (1)9,732
20137191414,955
20141119624 (15)15,399
20156156116,129
20160—2 (1)17,062
20174—6 (4)16,684
201820—316,591
201925—6 (2)16,861
202052—216,197
202141—416,300
202219—314,867
202324—1113,766
202427—515,109
202548—113,315
202631—3—

What is it indicated for?

Manual Defibrillation Indications: Defibrillation is a recognized means of terminating certain potentially 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, atria] flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Contraindications: Defibrillation is…

Read the full statement (234 words)

Manual Defibrillation

Indications: Defibrillation is a recognized means of terminating certain potentially 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, atria] flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.

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 patients ECG rhythm. In AED mode, the LIFEPAK 20 (and 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 Oximotry

Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

End-Tidal CO2 monitoring:

Indications: EtCO 2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Indications for use as stated in the FDA summary.

Also cleared against K012274

3 other devices cite the same predicate.

  • K073089Lifepak 20EPhysio-Control, Inc. · 20081 recall
  • K063119Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc. · 20065 recalls
  • K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 20031 recall

More from Physio-Control, Inc.

119 FDA decisions under this applicant name. See the company

  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026
  • P160026/S069LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc. · 2026
  • P160026/S072Physio-Control LIFEPAK®35 monitor/defibrillatorPhysio-Control, Inc. · 2026
  • P160026/S071LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc. · 2026

Recent decisions in MKJ

The MKJ category page

  • P160015/S029AED 3 Defibrillator with Uni-PadzZOLL Medical Corporation · 2026
  • P160022/S056ZOLL R Series Monitor/DefibrillatorZOLL Medical Corporation · 2026
  • P160022/S054X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 2026
  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026

https://510kreport.com/device/K130454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130454: Lifepak 20 Defibrillator/Monitor, Lifepak 20E 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/K130454

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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