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Tracheostomy Care Set with Gloves

by American Healthcare Corp.

510(k) K923834

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 NumberK923834 Date10 Dec 1992ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

This device is a Tracheostomy Care Set with Gloves, designed for the maintenance and cleaning of tracheostomy tubes. It includes sterile supplies to facilitate safe and hygienic care of tracheostomy sites, reducing the risk of infection and ensuring proper tube maintenance in clinical settings.

The set is intended for single-use in hospital or home care environments, providing gloves for aseptic technique and additional supplies for cleaning and dressing the tracheostomy site. Supplied sterile, it adheres to Class II regulatory standards under FDA 510(k) clearance (K923834) and is categorized under product code BTO. No MRI safety or reusable specifications are indicated.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Tracheostomy Care Set with Gloves used for?

    This set is designed for the maintenance and cleaning of tracheostomy tubes in both hospital and home care environments. It includes sterile supplies to help maintain proper hygiene at the tracheostomy site, reducing the risk of infection during routine care procedures.

  • Is this tracheostomy care set sterile and for single-use only?

    Yes, the set is supplied sterile and is intended for single-use only. This ensures aseptic technique during tracheostomy care, minimizing contamination risks for both the patient and clinician.

  • What supplies are included in the set, and how are they used?

    The set includes sterile gloves for aseptic technique, along with additional supplies for cleaning and dressing the tracheostomy site. The gloves help maintain hygiene while handling the tube, and the included items facilitate safe and effective maintenance procedures.

  • Can this tracheostomy care set be reused?

    No, this set is explicitly designed for single-use only. Reusing it could compromise sterility and increase the risk of infection, which is why it is not intended for reuse in any setting.

  • How should the tracheostomy care set be stored before use?

    The set should be stored in a clean, dry, and sealed environment to maintain sterility until use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could compromise the integrity of the sterile barrier.