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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 a medical device manufactured by Idmed. It received FDA 510(k) clearance on 2025-08-12 under approval 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. It is manufactured by Idmed. The 510(k) number is K243562.

When was CuffGuard approved by the FDA?

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

What company makes CuffGuard?

CuffGuard is manufactured by Idmed.

What is the FDA product code for CuffGuard?

The FDA product code for CuffGuard is BSK.

Other Devices by Idmed

K172690ToFscan K243339WiTOF

Related Devices (Code: BSK)

K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbH K152865TRACOE smart Cuff ManagerTracoe Medical GmbH K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration , Ltd. K150893IntelliCuffHamilton Medical AG K180991AG 100sHospitech Respiration , Ltd. K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc.

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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