Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM

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

510(k) Number

K894337 ↗

FDA Product Code

CBI

Device Class

Class II

Regulation

21 CFR Part 868.5740

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Agishi Ascites Pump Peritoneocaval Shunt Pump

  Class II

  FDA 510(k) K894794 Active Cleared 21 Nov 1989

• Selfcath

  Class II

  FDA 510(k) K901738 Active Cleared 27 Jun 1990

• Wire Reinforced Endotracheal Tube

  Class II

  FDA 510(k) K932647 Active Cleared 2 Nov 1993

• Pediatric Cuffed and Uncuffed Et Tubes; Standard Cuffed and Uncuffed Et Tubes

  Class II

  FDA 510(k) K050803 Active Cleared 30 Jun 2005

• Laser Shielding Tube

  Class II

  FDA 510(k) K894669 Active Cleared 13 Oct 1989

• Phycon All Silicone Balloon Catheter

  Class II

  FDA 510(k) K894883 Active Cleared 25 Apr 1990

• What is the Univent Tube used for?

  The Univent Tube is a tracheal/bronchial differential ventilation device designed to facilitate one-lung ventilation. It is intended for use in anesthesia and thoracic procedures requiring differential lung ventilation, allowing the blocker to be positioned in the right or left mainstem bronchus or used to block specific lung segments.

• What sizes are available for the Univent Tube?

  The Univent Tube is supplied in five sizes: 7.0mm, 7.5mm, 8.0mm, 8.5mm, and 9.0mm. These sizes accommodate different patient anatomies and clinical requirements for differential ventilation during thoracic procedures.

• How is the Univent Tube designed for intubation and blocking?

  The device features a malleable shaft for smooth intubation into the target bronchus and a flexible blocker with a soft open lumen tip that allows for smooth manipulation. The blocker can be positioned in either the right or left mainstem bronchus, or used to block specific lung segments, and its lumen supports CPAP, insufflation, or air exhaustion.

• What regulatory clearance does the Univent Tube have?

  The Univent Tube has received FDA 510(k) clearance under the Traditional pathway with a substantially equivalent decision. The clearance was granted on September 29, 1989, under K-number K894337, with the device classified under product code CBI for tracheal/bronchial differential ventilation devices.

• What clinical specialty is the Univent Tube associated with?

  The Univent Tube is associated with the clinical specialty of Anesthesiology, as indicated by the advisory committee review and medical specialty designation. It is primarily used in anesthesia and thoracic surgical procedures requiring differential lung ventilation.