# K011046: Autopulse, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Revivant Corp.
- Decided: Oct 25, 2001 after 202 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022345: Autopulse Resuscitation System (2002), 16 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K011046
Methodology: https://510kreport.com/methodology