# K161768: LUCAS 3 Chest Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Jolife AB
- Decided: Nov 9, 2016 after 135 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: 7 generations back to K851139 (1985). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090422: LUCAS 2, Jolife AB (2009) Summary page 4.

## Most influential descendants
- 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

## 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.

## 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. The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

Source page: https://510kreport.com/device/K161768
Methodology: https://510kreport.com/methodology