Cleared Traditional

Hexoskin Medical System (7100-00016)

K243981 · Carre Technologies, Inc. · Cardiovascular

Nov 2025

Decision

330d

Days

Class 2

Risk

About This 510(k) Submission

K243981 is an FDA 510(k) clearance for the Hexoskin Medical System (7100-00016), a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Carre Technologies, Inc. (Montreal, CA). The FDA issued a Cleared decision on November 18, 2025, 330 days after receiving the submission on December 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K243981 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	November 18, 2025
Days to Decision	330 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF