510(k) · Cleared

Cleared

Heartstart 3000

K896919510(k) TraditionalCleared May 3, 1990142-day reviewClass III21 CFR 870.5310

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

Laerdal Medical Corp. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on May 3, 1990 after a 142-day review. FDA has not posted a summary or statement for it, 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.

Decided: May 3, 1990
Review: 142 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 0

26 later devices descend from it, 1 citing it directly. 4 of the 27 devices in this family, counting this one, have a Class I recall.

This deviceK896919 Heartstart 3000Laerdal Medical Corp. · 1990
Descendant · cites it directly · 25 of its ownK983393 Lifepak 500 BiphasicPhysio-Control Corp. · 1999 · Recalled
Descendant · 2 generations on · 22 of its ownK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
Descendant · 3 generations on · 21 of its ownK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
Descendant · 2 generations on · 21 of its ownK012428 Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001 · Recalled
Descendant · 2 generations on · 20 of its ownK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled

Showing 5 of 26 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…3 generations on · 2013
K122600 Lifepak 1000 Defibrillator3 generations on · 2012
K052465 Reduced Energy Pediatric Electrode Pads for the…3 generations on · 2006
K142430 LIFEPAK 15 monitor/defibrillator4 generations on · 2014

Most influential descendants

Showing 5 of 26 · See all

K983393Lifepak 500 BiphasicPhysio-Control Corp. · 1999 · cites it directly25descendants
K991910Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · 2 generations on22descendants
K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · 3 generations on21descendants
K012428Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001 · 2 generations on21descendants
K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · 2 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K896919	Heartstart 3000	Laerdal Medical Corp.	1990	—
+1	K983393	Lifepak 500 Biphasic	Physio-Control Corp.	1999	1
+2	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	K012428	Modification to: Lifepak 500 Automated External Defibrillator	Medtronic Physio-Control Corp.	2001	2
+2	K033275	Lifepak 12, 20, 500, CR Plus	Medtronic Physio-Control Corp.	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	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 K896919, 1990–2025Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (26)

See all 26

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983393	Lifepak 500 Biphasic	Physio-Control Corp.	1999	25

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

No FDA recall names this device.

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
K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 3 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 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Of its descendants, K983393 (Physio-Control Corp., 1999) has gone furthest, with 25 descendants of its own.

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	—

https://510kreport.com/device/K896919 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896919: Heartstart 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896919

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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