# K243981: Hexoskin Medical System (7100-00016)

- Pathway: 510(k) (Traditional)
- Applicant: Carre Technologies, Inc.
- Decided: Nov 18, 2025 after 330 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K882803 (1988). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201669: SimpleSENSE, Nanowear, Inc. (2020) Summary page 5.

## Indications for use
The Hexoskin Medical System (HMS) is intended for use at home, or at a healthcare facility, on the order of a licensed medical professional, to record, display and store the following physiological data: a) 3 leads of electrocardiogram; b) heart rate; c) respiratory rate; and d) activity. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The HMS ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

Source page: https://510kreport.com/device/K243981
Methodology: https://510kreport.com/methodology