D.I.C. Tracheostomy Tubes & Laryngectomy Tubes

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

510(k) Number

K903730 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Suction Control Valve

  Class I

  FDA 510(k) K892343 Active Cleared 24 Apr 1989

• Accu-Vent(Tm) with Needle-Pro(Tm)

  Class I

  FDA 510(k) K912043 Active Cleared 5 Jul 1991

• Needle-Pro Cartridge

  Class II

  FDA 510(k) K923127 Active Cleared 29 Apr 1993

• Subcutaneous Tunneling Needle and Handles

  Class II

  FDA 510(k) K930218 Active Cleared 27 Jul 1993

• Heat Moisture Condenser

  Class I

  FDA 510(k) K923910 Active Cleared 26 Jan 1993

• Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K915452 Active Cleared 14 Feb 1992

See all devices from Concord/Portex →

• What is the purpose of the D.I.C. Tracheostomy Tubes & Laryngectomy Tubes?

  These tubes are designed to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff, when inflated, creates a seal between the tracheal wall and the tube.

• How are the D.I.C. Tracheostomy Tubes supplied and what is their sterility status?

  The device is supplied as a sterile product. The clear, soft, pliable flange is specifically designed to provide patient comfort and anatomical conformity, allowing caregivers to view and access the stoma site for cleaning.

• What regulatory status does the D.I.C. Tracheostomy Tubes have?

  The D.I.C. Tracheostomy Tubes & Laryngectomy Tubes are FDA 510(k) cleared as substantially equivalent with a product code of BTO and regulation number 868.5800. They were cleared by Concord/Portex on September 25, 1990.

• What sizes and models of D.I.C. Tracheostomy Tubes are available?

  The device comes in various sizes and models to accommodate different patient needs. The specific sizes and models are not detailed in the provided information, but the device is classified under medical specialty anesthesiology.