510(k) · Cleared

Cleared

Zoll M Series 12SL Analysis Option

K051475510(k) SpecialCleared Jun 24, 200521-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

ZOLL Medical Corporation · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jun 24, 2005 as substantially equivalent to K991556 (Zoll Medical Corp, 1999) after a 21-day review. Its family tree reaches back 1 generation to 1999.

Decided: Jun 24, 2005
Review: 21 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K991556 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK991556 Zoll M Series 12SL Analysis OptionZoll Medical Corp · 1999
This deviceK051475 Zoll M Series 12SL Analysis OptionZOLL Medical Corporation · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991556	Zoll M Series 12SL Analysis Option	Zoll Medical Corp	1999	—
0 (this device)	K051475	Zoll M Series 12SL Analysis Option	ZOLL Medical Corporation	2005	—

FIG. 1 — Lineage of K051475, 1999–2005Source: 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
*	K991556	Zoll M Series 12SL Analysis Option Summary page 1 …) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) Invasive Blood Pressure and Temperature (K011865) and dat…	Zoll Medical Corp	1999	—
†	K972241	Zoll Reviver	Zoll Medical Corp	1998	1
†	K982992	Zoll M Series SPO2 Option	Zoll Medical Corp	1999	—
†	K993036	Zoll M Series ETCO2 Option	Zoll Medical Corp	2000	—
†	K002029	Zoll M Series Nibp Option, Model Mseries Nibp Option	Zoll Medical Corp	2000	—
†	K011865	Zoll M Series Ibp Operation; Zoll M Series Temperature Option	Zoll Medical Corp	2001	—

Also cleared against K991556: 1 other 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)

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.
1 other device also cites its predicate K991556.

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 12-Lead ECG Analysis is useful in the diagnosis and treatment of patient with acute myocardial infarction (AMI). 12-Lead ECG Analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the 12-Lead analysis results can be of assistance in diagnosis and treatment decisions once the patient has arrived in the hospital emergency department.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051475 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051475: Zoll M Series 12SL Analysis Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051475

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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