Mini-Trach Kit

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

510(k) Number

K862167 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Trocar Catheter/Thoracic Catheter

  Class II

  FDA 510(k) K792202 Active Cleared 20 Nov 1979

• Thermovent 600, 1200, T, 02

  Class I

  FDA 510(k) K874597 Active Cleared 19 Jan 1988

• Blue Line Ultra Suctionaid Tracheostomy Tube

  Class II

  FDA 510(k) K030570 Active Cleared 17 Sep 2003

• Jet Ventilation Adaptor

  Not classified

  FDA 510(k) K842456 Active Cleared 6 Jul 1984

• 1ST Response Intermediate Manual Resuscitator

  Class II

  FDA 510(k) K023793 Active Cleared 11 Feb 2003

• Reinforced Silicone Tracheal Tube

  Class II

  FDA 510(k) K830352 Active Cleared 8 Mar 1983

See all devices from Portex, Ltd. →

• What is the Mini-Trach Kit used for?

  The Mini-Trach Kit is a tracheostomy care kit specifically designed for performing mini-tracheostomy procedures and managing the tracheo-bronchial tree in various clinical applications.

• How is the Mini-Trach Kit supplied and what is its sterility status?

  The kit is supplied sterile and is latex-free, ensuring it meets safety standards for clinical use. It is intended for single-use only and should not be reused on different patients.

• What is the regulatory classification of the Mini-Trach Kit?

  The Mini-Trach Kit is classified as a Class II medical device and has FDA 510(k) clearance with the product code BTO. It is manufactured by Portex, Inc. and is substantially equivalent to other devices in this category.

• What sizes or models of the Mini-Trach Kit are available?

  The device data does not specify different sizes or models of the Mini-Trach Kit. The kit appears to be a standardized product designed for general mini-tracheostomy procedures without variations mentioned in the available information.