FDA 510(k)

CuffGuard

K-Number: K243562 · 2025-08-12

ApplicantIdmed

Decision Date2025-08-12

Product CodeBSK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CuffGuard is the device name listed in this FDA 510(k) record. The listed applicant is Idmed. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K243562. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuffGuard?

CuffGuard is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Idmed. The 510(k) number is K243562.

When did CuffGuard receive FDA 510(k) clearance?

CuffGuard received FDA 510(k) clearance on 2025-08-12, under 510(k) number K243562.

Who is the listed applicant for CuffGuard?

The FDA 510(k) record lists Idmed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CuffGuard?

The FDA product code for CuffGuard is BSK.

Other records listing Idmed as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243339WiTOF K172690ToFscan

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Official Source

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