Ohmeda Tec 5 Vaporizer for Sevoflurane

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

Full name

Ohmeda Tec 5 Vaporizer for Use with Sevoflurane

510(k) Number

K942091 ↗

FDA Product Code

CAD

Device Class

Class II

Regulation

21 CFR Part 868.5880

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

  Class II

  FDA 510(k) K072157 Active Cleared 27 Aug 2007

• Ohmeda Medical Omnibed

  Class II

  FDA 510(k) K993407 Active Cleared 5 Jan 2000

• Ohmeda 7900 Anesthesia Ventilator

  Class II

  FDA 510(k) K960964 Active Cleared 27 Sep 1996

• Biliblanket Plus High Output Phototherapy System

  Class II

  FDA 510(k) K993712 Active Cleared 9 Nov 1999

• Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K871398 Active Cleared 7 May 1987

• Ohmeda 9000 Syringe Pump

  Class II

  FDA 510(k) K896023 Active Cleared 4 Jan 1990

See all devices from Ohmeda Medical →

• Is the Ohmeda Tec 5 Vaporizer designed for single-use or can it be reused in clinical settings?

  The Ohmeda Tec 5 Vaporizer is explicitly supplied as a reusable medical instrument. It requires proper maintenance, calibration, and adherence to regulatory standards to ensure safe and reliable performance over multiple uses. Since it is classified as a Class II device, routine servicing and compliance checks are necessary to maintain its accuracy and functionality.

• What types of anesthesia machines is the Tec 5 Vaporizer compatible with, and how is it filled?

  The Tec 5 is designed for use with Datex-Ohmeda anesthesia machines and select Drager models. It features a fill system that includes Key Fill or Funnel Fill options, both of which are engineered to minimize leaks during refueling with sevoflurane, ensuring precise vapor concentration delivery.

• How does the Tec 5 Vaporizer maintain consistent vapor output under varying environmental conditions?

  The Tec 5 incorporates temperature-, flow-, and pressure-compensation mechanisms to stabilize vapor output despite cooling from evaporation. This design ensures reliable and accurate sevoflurane delivery regardless of external temperature or flow rate fluctuations, making it suitable for clinical settings where environmental conditions may vary.

• What regulatory pathway was followed for the FDA clearance of this device, and what specialty does it fall under?

  The Tec 5 Vaporizer received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). It was evaluated by the Anesthesiology (AN) Advisory Committee and is classified under the anesthesia vaporizer (CAD) product code. The device is regulated within the Anesthesiology specialty and is intended for use in inhalation anesthesia delivery systems.