510(k) Report

PMA · Approved

Recalled · Class II · 2026

Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak 15 Monitor/DE

P160026PMAApproved Jul 2, 2018707-day reviewClass III21 CFR 870.5310Recalls 17

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)

Approved on Jul 2, 2018 through premarket approval, which rests on the device’s own clinical evidence after a 707-day review. It has been recalled 17 times.

Decided
Jul 2, 2018
Review
707 days
Class
Class III
Product code
MKJ
Recalls
17

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P160026 has 71 supplements since 2018: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2018: 32019: 82020: 82021: 82022: 72023: 82024: 82025: 112026: 10
2018high 11 (2025) · low 3 (2018)2026
View FIG. 1 as a table
YearSupplements approved
20183
20198
20208
20218
20227
20238
20248
202511
202610
FIG. 1 — Supplements to P160026, 2018–2026Source: FDA PMA database

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

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MKJ? 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
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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 13, 2026Class IIZ-2065-2026Process controlSome defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result…
Jul 22, 2025Class IIZ-2497-2025Under Investigation by firmDue to required inspections not being performed on products/units that have gone through servicing.
Jul 22, 2025Class IIZ-2498-2025Under Investigation by firmDue to required inspections not being performed on products/units that have gone through servicing.
Feb 3, 2025Class IIZ-1232-2025Employee errorIncorrect keypad was incorrectly installed onto a defibrillator/monitor.
Jan 21, 2025Class IIZ-1184-2025Device DesignDue to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Aug 30, 2024Class IIZ-0230-2025Vendor change controlDue to an out of tolerance tool being used on monitor/defibrillator systems.
Nov 6, 2023Class IIZ-0567-2024Component change controlAC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
Sep 29, 2023Class IIZ-0296-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0297-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0300-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0301-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0299-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0303-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0304-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0298-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0302-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Sep 29, 2023Class IIZ-0305-2024Under Investigation by firmTheir is a potential for battery pins to become loose within the defibrillator resulting in power issues.

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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. 2018, 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—

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/P160026 · printed Nov 6, 2026

Cite this page

510(k) Report. “P160026: Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak 15 Monitor/DE.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160026

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026