# K153628: ROSC-U Mini Chest Compressor (RMCC)

- Pathway: 510(k) (Traditional)
- Applicant: Resuscitation International, LLC
- Decided: Jan 30, 2016 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: 7 generations back to K851139 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102068: Miniaturize Chest Compressor (MCC), Resuscitation International (2010) Summary page 4.
- K090422: LUCAS 2, Jolife AB (2009) Summary page 4.

## Indications for use
To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Source page: https://510kreport.com/device/K153628
Methodology: https://510kreport.com/methodology