510(k) · Cleared

Cleared

Lifepak 300

K962359510(k) TraditionalCleared Nov 6, 1997505-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

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

Cleared on Nov 6, 1997 as substantially equivalent to K925936 (Physio-Control Corp., 1994) after a 505-day review. Its family tree reaches back 1 generation to 1994.

Decided: Nov 6, 1997
Review: 505 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925936 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK925936 Lifepak 300 Automatic Advisory DefrillatorPhysio-Control Corp. · 1994
This deviceK962359 Lifepak 300Physio-Control Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925936	Lifepak 300 Automatic Advisory Defrillator	Physio-Control Corp.	1994	—
0 (this device)	K962359	Lifepak 300	Physio-Control Corp.	1997	—

FIG. 1 — Lineage of K962359, 1994–1997Source: 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.

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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What was it cleared against? (1)

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
*	K925936	Lifepak 300 Automatic Advisory Defrillator Summary page 1 …Equivalence: The intended use and function of the LIFEPAK 300 defibrillator (modified) are substantially equivalent to those of the LIFEPAK 300 defibrillator 510(k) no. K925936. : The unmodified LIFEPAK 300 AED (510(k) no. K925936) will not allow the operator to deliver a shock if the device detects moti…	Physio-Control Corp.	1994	—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no 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.

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?

For emergency treatment of patients in cardiac arrest who are unconscious and

lack pulse and spontaneous breath. The device may be used for automated

ECG analysis or, alternatively as a standard cardiac monitor formanual ECG

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/K962359 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962359: Lifepak 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962359

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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