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Tracheostomy Care Set W/Extra Towel (AHC-20-54686)

by American Healthcare Corp.

510(k) K924194

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK924194 Date6 Jan 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTO
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tracheostomy Care Set W/Extra Towel (AHC-20-54686) is a tracheostomy tube kit. It is designed to facilitate the maintenance and care of a tracheostomy tube.

This device is supplied by American Healthcare Corp. and has received FDA 510(k) clearance under K924194. It is classified as a class 2 medical device under regulation 868.5800.

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