# K022345: Autopulse Resuscitation System

- Pathway: 510(k) (Special)
- Applicant: Revivant Corp.
- Decided: Aug 15, 2002 after 27 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851139 (1985). 2 ancestors in all.
16 later devices descend from it; 3 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011046: Autopulse, Model 100, Revivant Corp. (2001)
- K851139: Thumper Cardiopulmonary Resuscitator 1005, Michigan Instruments, Inc. (1985) Summary page 1.

## Most influential descendants
- K032852: Modification to: Autopulse Resuscitation System Model 100 (2003), 15 descendants of its own
- K040453: Autopulse Resuscitation System, Model 100 (2004), 14 descendants of its own
- K063602: Autopulse Resuscitation System  MODEL100 (2006), 11 descendants of its own
- K053403: LUCAS (2006), 7 descendants of its own
- K073079: Thumper, Model: 1008 (2008), 6 descendants of its own

## Recalls of this device
- Jul 16, 2013 · Class III · Z-2090-2014: Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
- Aug 8, 2012 · Class II · Z-0658-2013: Complaints associated with an unexpected stop in AutoPulse compressions.

## 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/K022345
Methodology: https://510kreport.com/methodology