# K051475: Zoll M Series 12SL Analysis Option

- Pathway: 510(k) (Special)
- Applicant: ZOLL Medical Corporation
- Decided: Jun 24, 2005 after 21 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991556 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991556: Zoll M Series 12SL Analysis Option, Zoll Medical Corp (1999) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K051475
Methodology: https://510kreport.com/methodology