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FDA 510(k)

Hexoskin Medical System (7100-00016)

K-Number: K243981 · 2025-11-18

ApplicantCarre Technologies, Inc.
Decision Date2025-11-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hexoskin Medical System (7100-00016) is a medical device manufactured by Carre Technologies, Inc.. It received FDA 510(k) clearance on 2025-11-18 under approval number K243981. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hexoskin Medical System (7100-00016)?

Hexoskin Medical System (7100-00016) is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Carre Technologies, Inc.. The 510(k) number is K243981.

When was Hexoskin Medical System (7100-00016) approved by the FDA?

Hexoskin Medical System (7100-00016) received FDA 510(k) clearance on 2025-11-18, under approval number K243981.

What company makes Hexoskin Medical System (7100-00016)?

Hexoskin Medical System (7100-00016) is manufactured by Carre Technologies, Inc..

What is the FDA product code for Hexoskin Medical System (7100-00016)?

The FDA product code for Hexoskin Medical System (7100-00016) is DXH. This falls under the Hematology category.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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