TrachFlush

FDA 510(k) K261499 · Aw Technologies Aps

Substantially Equivalent

510(k) numberK261499

Submission

Device name
TrachFlush
Applicant
Aw Technologies Aps
Norresundby, DK
Received
May 6, 2026
Decision date
August 13, 2026
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 TrachFlush cleared by the FDA?

TrachFlush (K261499) received a 510(k) decision of Substantially Equivalent on August 13, 2026, 99 days after the submission was received.

What is the product code of K261499?

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