CuffGuard

FDA 510(k) K243562 · Idmed

Substantially Equivalent

510(k) numberK243562

Submission

Device name
CuffGuard
Applicant
Idmed
Marseille, FR
Received
November 18, 2024
Decision date
August 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSK – Cuff, Tracheal Tube, Inflatable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5750
Specialty
Anesthesiology
Life-sustaining
Yes

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Questions and answers

When was CuffGuard cleared by the FDA?

CuffGuard (K243562) received a 510(k) decision of Substantially Equivalent on August 12, 2025, 267 days after the submission was received.

What is the product code of K243562?

The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.