Skip to content

Tracheostomy Care Kit

by Trinity Laboratories, Inc. 510(k)

Active United States

510(k) K920281

Overview

The Tracheostomy Care Kit is a medical device classified as a tracheostomy tube with or without a connector. It is designed to facilitate the maintenance and care of tracheostomy sites.

This device is supplied as a sterile, single-use kit to help reduce the risk of cross-contamination. It is regulated as a Class II device under FDA 510(k) clearance K920281.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK920281 Date27 Aug 1992ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Tracheostomy Care Kit, Sterile, Disposable
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

Other devices from Trinity Laboratories, Inc.

See all devices from Trinity Laboratories, Inc. →

Questions

  • What is the primary purpose of this kit?

    The Tracheostomy Care Kit is designed to facilitate the maintenance and care of tracheostomy sites. It is classified as a tracheostomy tube with or without a connector.

  • Is this device intended for multiple uses?

    No, this device is supplied as a single-use kit. This design is intended to help reduce the risk of cross-contamination during the care of tracheostomy sites.

  • Is the kit provided in a sterile condition?

    Yes, the kit is supplied as a sterile product to ensure it is ready for safe use in clinical environments while minimizing contamination risks.

  • What is the regulatory status of this device?

    This device is regulated as a Class II medical device under FDA 510(k) clearance K920281, which was granted under the Anesthesiology advisory committee.