# K991556: Zoll M Series 12SL Analysis Option

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Oct 21, 1999 after 170 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
No predicates in its family tree.
66 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K042007: Zoll E Series Defibrillator (2005), 64 descendants of its own
- K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series (2009), 27 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K060559: Zoll R Series Defibrillator (2006), 21 descendants of its own
- K171121: Masimo Root Monitoring System and Accessories (2017), 16 descendants of its own

## Indications for use
The 12-lead ECG Analysis is useful in the diagnosis and treatment of patients 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/K991556
Methodology: https://510kreport.com/methodology