Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9mm Tubes Only

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

510(k) Number

K040014 ↗

FDA Product Code

JOH

FDA applicant

Portex , Ltd.

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. →