TrachFlush— 510(k) K261499

Substantially Equivalent

Aw Technologies Aps

FDA 510(k) clearance K261499 for TrachFlush, Substantially Equivalent on 2026-08-13. Applicant: Aw Technologies Aps. Device class: 2.

Clearance details

Applicant: Aw Technologies Aps
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2026-05-06
Decision date: 2026-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norresundby, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSK

K243562 — CuffGuard2025-08-12
K242642 — CuffTrek2025-03-07
K220854 — TrachCuff Cuff Controller2023-04-14
K221477 — AG100s2022-12-29
K202874 — Puritan Bennett Cuff Pressure Manager2021-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.