Cleared Traditional

K243981 - Hexoskin Medical System (7100-00016) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K243981 · Carre Technologies, Inc. · Cardiovascular device
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Nov 2025
Decision
330d
Days
Class 2
Risk

K243981 is an FDA 510(k) clearance for the Hexoskin Medical System (7100-00016). Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Carre Technologies, Inc. (Montreal, CA). The FDA issued a Cleared decision on November 18, 2025 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Carre Technologies, Inc. devices

Submission Details

510(k) Number K243981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 125d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05970328 Completed Observational Industry-sponsored

Hexoskin Medical System - ECG Performance Testing

HMS ECG Clinical Validation Study - Protocol External Site

75
Patients (actual)
2
Sites
Condition studied Cardiac Rhythm Disturbance
Eligibility All sexes · 21 Years+
Principal investigator Christopher Cheung, MD
Sponsor Carré Technologies Inc. (industry)
Started 2023-07-24 → Primary completion 2024-02-17
Primary outcome
ECG characteristics measurement agreement
Secondary outcome
Heart rate agreement
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 296
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K243981.
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