# K090422: LUCAS 2

- Pathway: 510(k) (Traditional)
- Applicant: Jolife AB
- Decided: Jun 17, 2009 after 119 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K851139 (1985). 11 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062401: Modification to Lucas, Jolife AB (2006) Summary page 1.
- K073079: Thumper, Model: 1008, Michigan Instruments, Inc. (2008) Summary page 1.
- K072527: Autopulse Resuscitation System, Model 100, Zoll Circulation (2008) Summary page 1.

## Most influential descendants
- 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
- K141809: Rmu-1000 Automated Chest Compression System (2014), 0 descendants of its own

## Recalls of this device
- Apr 13, 2026 · Class II · Z-2161-2026: Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing result
- May 21, 2025 · Class II · Z-1998-2025: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
- Feb 8, 2011 · Not classified · Z-1664-2011: LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will st

## Indications for use
LUCAS Chest Compression System 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 chest compressions are likely to help the patient.

Source page: https://510kreport.com/device/K090422
Methodology: https://510kreport.com/methodology