510(k) · Cleared

Recalled · Class II · 2020

Lifepak 500 Biphasic

K983393510(k) TraditionalCleared May 5, 1999222-day reviewClass III21 CFR 870.5310Recalls 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. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on May 5, 1999 as substantially equivalent to K955854 (Physio-Control Corp., 1996) and 3 other predicates after a 222-day review. Its family tree reaches back 2 generations to 1995. 4 of the 32 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it. It has been recalled once.

Decided: May 5, 1999
Review: 222 days
Class: Class III
Product code: MKJ
Recalls: 1
Predicates: 4

Its longest line of descent runs back 2 generations to K943301 (1995). 6 ancestors in all, the oldest K832833 (1984). 25 later devices descend from it, 6 citing it directly. 4 of the 32 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK943301 Quik ComboPhysio-Control Corp. · 1995
1 generation backK955854 Lifepak 500Physio-Control Corp. · 1996 · Recalled
This deviceK983393 Lifepak 500 BiphasicPhysio-Control Corp. · 1999
Descendant · cites it directly · 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 · cites it directly · 21 of its ownK012428 Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001 · Recalled
Descendant · cites it directly · 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 25 descendants. See all descendants

Descendants cleared per year

1999high 3 (2006) · low 0 (2000)2026

Class I recalls in this family

K130454 Lifepak 20 Defibrillator/Monitor, Lifepak 20E…2 generations on · 2013
K122600 Lifepak 1000 Defibrillator2 generations on · 2012
K052465 Reduced Energy Pediatric Electrode Pads for the…2 generations on · 2006
K142430 LIFEPAK 15 monitor/defibrillator3 generations on · 2014

Most influential descendants

Showing 5 of 25 · See all

K991910Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · cites it directly22descendants
K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · 2 generations on21descendants
K012428Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001 · cites it directly21descendants
K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · cites it directly20descendants
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
−2	K943301	Quik Combo	Physio-Control Corp.	1995	—
−1	K955854	Lifepak 500	Physio-Control Corp.	1996	2
0 (this device)	K983393	Lifepak 500 Biphasic	Physio-Control Corp.	1999	—
+1	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	K012428	Modification to: Lifepak 500 Automated External Defibrillator	Medtronic Physio-Control Corp.	2001	2
+1	K033275	Lifepak 12, 20, 500, CR Plus	Medtronic Physio-Control Corp.	2003	1
+2	K040775	Lifepak 12	Medtronic Physio-Control Corp.	2004	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1990	1	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	2	0
2003	1	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 K983393, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K955854	Lifepak 500 Summary page 1 …ubstantial Equivalence: This defibrillator is substantially equivalent to the currently marketed Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED,…	Physio-Control Corp.	1996	2
*	K832833	Personal Defibrillator Summary page 1 …r is substantially equivalent to the currently marketed Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED, 510(k) no. K896919, and the Mine Safety an…	Physio-Control, Inc.	1984	—
*	K955628	Fore Runner External Defibrillator/Defibrillator Pads Summary page 1 …ted Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED, 510(k) no. K896919, and the Mine Safety and CRC Heart Aid defibrillators, both Preamendment de…	Heartstream, Inc.	1996	—
*	K896919	Heartstart 3000 Summary page 1 …brillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED, 510(k) no. K896919, and the Mine Safety and CRC Heart Aid defibrillators, both Preamendment devices. Description: The Biphasic LIFEPAK 500 Automat…	Laerdal Medical Corp.	1990	—
*	—	Mine Safety Heart Aid defibrillator Named without a submission number			—
*	—	CRC Heart Aid defibrillator Named without a submission number			—

Also cleared against K955854: 3 other devices →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K991910	Lifepak 12 Biphasic	Physio-Control Corp.	1999	22
K012428	Modification to: Lifepak 500 Automated External Defibrillator	Medtronic Physio-Control Corp.	2001	21
K033275	Lifepak 12, 20, 500, CR Plus	Medtronic Physio-Control Corp.	2003	20
K052057	Lifepak 500 Automated External Defibrillator	Medtronic Emergency Response Systems, Inc.	2006	4
K042404	Lifepak, Model 1000	Medtronic Emergency Response Systems, Inc.	2005	1
K020984	Accessaed, Semi-Automatic External Defibrillators	Access Cardiosystems, Inc.	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 20, 2020	Class II	Z-1633-2020	Device Design	Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which…

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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 2 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 · 2 generations on · ◆ in the 2006 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

What does this lineage say?

The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K991910 (Physio-Control Corp., 1999) has gone furthest, with 22 descendants of its own.
3 other devices also cite its predicate K955854.

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.

FDA decisions per year · MKJ

48in 2025

2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007high 250 (2010) · low 36 (2011)2026

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

Recalls per year · MKJ

1in 2025

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

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

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?

The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patnent must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. [t is not intended for use on children less than eight years of age, per AttA @W .

The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training:

CPR training

AED training equivalent to that recommended by the American heart Association

Training in the use of the LIFEPAK 500 AED

Federal law restricts this device to sale by or on the order of a physician.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983393: Lifepak 500 Biphasic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983393

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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