# K180479: ReDS System

- Pathway: 510(k) (Traditional)
- Applicant: Sensible Medical Innovations, Ltd.
- Decided: Feb 28, 2019 after 371 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000126 (2000). 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)
- K150095: ReDs Wearable System, Sensible Medical Innovations, Ltd. (2015) Summary page 4.

## Indications for use
The ReDS System is intended for use by qualified healthcare practitioners, under the direction of a physician, in hospitals, hospital-type facilities and home environments, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. The ReDS System is indicated for patients: * With fluid management problems * Taking diuretic medication * Living with heart failure * Recovering from a coronary artery disease-related event

Source page: https://510kreport.com/device/K180479
Methodology: https://510kreport.com/methodology