Cleared Traditional

K261499 - TrachFlush

K261499 is an FDA 510(k) clearance for TrachFlush, manufactured by Aw Technologies Aps. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K261499 · Aw Technologies Aps · Anesthesiology device
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Aug 2026
Decision
99d
Days
Class 2
Risk

K261499 is an FDA 510(k) clearance for the TrachFlush. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Aw Technologies Aps (Norresundby, DK). The FDA issued a Cleared decision on August 13, 2026 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aw Technologies Aps devices

FDA 510(k) Submission Details - K261499

510(k) Number K261499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2026
Decision Date August 13, 2026
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSK Cuff, Tracheal Tube, Inflatable

All 29
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K261499.
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Cuffix
K192611 · Biovo Technologies , Ltd. · Aug 2020