# K112998: Autopulse Resuscitation System Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation
- Decided: Mar 15, 2012 after 160 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K851139 (1985). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072527: Autopulse Resuscitation System, Model 100, Zoll Circulation (2008) Summary page 1.
- K063602: Autopulse Resuscitation System  MODEL100, Zoll Circulation (2006) Summary page 1.
- K040453: Autopulse Resuscitation System, Model 100, Revivant Corp. (2004) Summary page 1.
- K032852: Modification to: Autopulse Resuscitation System Model 100, Revivant Corp. (2003) Summary page 1.
- K022345: Autopulse Resuscitation System, Revivant Corp. (2002) Summary page 1.
- K011046: Autopulse, Model 100, Revivant Corp. (2001) Summary page 1.

## Most influential descendants
- K221700: AutoPulse NXT Resuscitation System (2023), 0 descendants of its own

## Recalls of this device
- Sep 22, 2022 · Class II · Z-0118-2023: Due to increase in Li-Ion Battery failures

## Indications for use
The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Source page: https://510kreport.com/device/K112998
Methodology: https://510kreport.com/methodology