FDA 510(k)

TrachFlush

K-Number: K261499 · 2026-08-13

Decision Date2026-08-13

Product CodeBSK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TrachFlush is the device name listed in this FDA 510(k) record. The listed applicant is Aw Technologies Aps. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K261499. 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 TrachFlush?

TrachFlush is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Aw Technologies Aps. The 510(k) number is K261499.

When did TrachFlush receive FDA 510(k) clearance?

TrachFlush received FDA 510(k) clearance on 2026-08-13, under 510(k) number K261499.

Who is the listed applicant for TrachFlush?

The FDA 510(k) record lists Aw Technologies Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrachFlush?

The FDA product code for TrachFlush is BSK.

Other records listing Aw Technologies Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220854TrachCuff Cuff Controller

Related Devices (Code: BSK)

K243562CuffGuardIdmed K242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies Aps K221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC K192611CuffixBiovo Technologies , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.