# K062537: Zoll M Series with Real CPR Help

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Feb 28, 2007 after 183 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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 its predicate without a number.
- (no number) M Series Defibrillator: named in the summary without a submission number
- (no number) Other ZOLL Defibrillators equipped with CPR Feedback: named in the summary without a submission number

## Most influential descendants
- K141460: Finapres Nova Noninvasive Hemodynamic Monitor (2015), 4 descendants of its own
- K160967: Finapres Nova Noninvasive Hemodynamic Monitor (2017), 3 descendants of its own
- K173916: Finapres Nova Noninvasive Hemodynamic Monitor (2018), 2 descendants of its own
- K223332: Task Force CORE (2023), 0 descendants of its own
- K190228: Transcranial Doppler Ultrasound System (2019), 0 descendants of its own

## Indications for use
The M Series with Real CPR Help is intended to provide visual and audio feedback to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage the compression depth of greater than 1.5 to 2 inches for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age

Source page: https://510kreport.com/device/K062537
Methodology: https://510kreport.com/methodology