# K062401: Modification to Lucas

- Pathway: 510(k) (Traditional)
- Applicant: Jolife AB
- Decided: Sep 28, 2006 after 43 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: none
- 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.
6 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053403: LUCAS, Jolife AB (2006) Summary page 1.
- K972525: Thumper, Michigan Instruments, Inc. (1997) Summary page 1.
- K040453: Autopulse Resuscitation System, Model 100, Revivant Corp. (2004) Summary page 1.

## Most influential descendants
- K090422: LUCAS 2 (2009), 5 descendants of its own
- K161768: LUCAS 3 Chest Compression System (2016), 2 descendants of its own
- K173553: LUCAS 3 Chest Compression System (2018), 1 descendant of its own
- K211289: RMU-2000 Automated Chest Compression System (2021), 0 descendants of its own
- K153628: ROSC-U Mini Chest Compressor (RMCC) (2016), 0 descendants of its own

## Indications for use
LUCAS® External Cardiac Compressor is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. LUCAS® must only be used in cases where manual chest compression would be used. LUCAS® is only intended for temporary use.

Source page: https://510kreport.com/device/K062401
Methodology: https://510kreport.com/methodology