510(k) · Cleared

Recalled · 2008

Lifepak 11

K951593510(k) TraditionalCleared Dec 29, 1995267-day reviewClass II21 CFR 870.5550Recalls 1

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

Physio-Control Corp. · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Cleared on Dec 29, 1995 after a 267-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 27 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled once.

Decided: Dec 29, 1995
Review: 267 days
Class: Class II
Product code: DRO
Recalls: 1
Predicates: 0

26 later devices descend from it, 2 citing it directly. 4 of the 27 devices in this family, counting this one, have a Class I recall.

This deviceK951593 Lifepak 11Physio-Control Corp. · 1995
Descendant · cites it directly · 24 of its ownK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
Descendant · 2 generations on · 22 of its ownK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
Descendant · 2 generations on · 21 of its ownK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
Descendant · 3 generations on · 20 of its ownK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
Descendant · 2 generations on · 10 of its ownK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

1998high 3 (2006) · low 0 (2000)2026

Class I recalls in this family

K130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E…3 generations on · 2013
K142430 LIFEPAK 15 monitor/defibrillator3 generations on · 2014
K122600 Lifepak 1000 Defibrillator5 generations on · 2012
K052465 Reduced Energy Pediatric Electrode Pads for the…5 generations on · 2006

Most influential descendants

Showing 5 of 26 · See all

K973486Life Pak 12Physio-Control Corp. · 1998 · cites it directly24descendants
K991910Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · 2 generations on22descendants
K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · 2 generations on21descendants
K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · 3 generations on20descendants
K040775Lifepak 12Medtronic Physio-Control Corp. · 2004 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951593	Lifepak 11	Physio-Control Corp.	1995	—
+1	K973486	Life Pak 12	Physio-Control Corp.	1998	3
+2	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
+3	K033275	Lifepak 12, 20, 500, CR Plus	Medtronic Physio-Control Corp.	2003	1
+2	K040775	Lifepak 12	Medtronic Physio-Control Corp.	2004	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2002	1	0
2003	2	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

FIG. 1 — Lineage of K951593, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (26)

See all 26

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K973486	Life Pak 12	Physio-Control Corp.	1998	24
K982025	Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator	Hewlett-Packard Co.	1998	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 27, 2008	Not classified	Z-1567-2008	Labeling mix-ups	Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.

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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 5 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 · 5 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K973486 (Physio-Control Corp., 1998) has gone furthest, with 24 descendants of its own.

How does its category compare?

All DRO devices

DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRO

FDA has decided no DRO device since 2007.

Median 510(k) review, days · DRO

Too few DRO 510(k)s in any year since 2007 to give a median.

Recalls per year · DRO

12in 2020

2007high 12 (2020) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DRO

2in 2025

2007high 93 (2019) · low 0 (2022)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	7
2008	—	0	5
2009	—	0	3
2010	—	1	7
2011	—	0	3
2012	—	0	8
2013	—	0	11
2014	—	4 (4)	2
2015	—	0	41
2016	—	0	49
2017	—	0	15
2018	—	0	64
2019	—	0	93
2020	—	12	19
2021	—	0	22
2022	—	0	0
2023	—	0	6
2024	—	0	4
2025	—	0	2
2026	—	0	—

https://510kreport.com/device/K951593 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951593: Lifepak 11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951593

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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