# K150095: ReDs Wearable System

- Pathway: 510(k) (Traditional)
- Applicant: Sensible Medical Innovations, Ltd.
- Decided: Aug 6, 2015 after 202 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: 5 generations back to K000126 (2000). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131509: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, Inc. (2013) Summary page 5.
- K112830: Zoefluid Status Monitor (Model Zoe 2B), Noninvasive Medical Technologies, Inc. (2012) Summary page 5.
- K042113: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, LLC (2004) Summary page 5.
- K133301: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, Inc. (2014) Summary page 5.
- K070985: Aesculon CHF, Hypertension & Pacemaker Clinic, Osypka Medical, Inc. (2008) Summary page 5.
- K081035: Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2, Osypka Medical, Inc. (2008) Summary page 5.

## Most influential descendants
- K180479: ReDS System (2019), 0 descendants of its own

## Indications for use
ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. ReDS is indicated for patients: With fluid management problems Taking diuretic medication Living with Heart Failure Recovering from Coronary Artery Disease related event

Source page: https://510kreport.com/device/K150095
Methodology: https://510kreport.com/methodology