# K211289: RMU-2000 Automated Chest Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Defibtech, LLC
- Decided: Nov 9, 2021 after 195 days
- Product code: DRM (Compressor, Cardiac, External)
- Device class: 2
- Regulation: 21 CFR 870.5200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K851139 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173553: LUCAS 3 Chest Compression System, Jolife AB (2018) Summary page 5.

## Recalls of this device
- Jul 12, 2024 · Class I · Z-2543-2024: Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

## Indications for use
The RMU-2000 Automated Chest Compression System (ACC) 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. The RMU-2000 must only be used in cases where chest compressions are likely to help the patient. The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients 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 personnel are available to provide effective CPR).

Source page: https://510kreport.com/device/K211289
Methodology: https://510kreport.com/methodology