# K990132: Datex-Ohmeda Anesthesia Vaporizer, Model D-Tec

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jan 21, 1999 after 7 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ohmeda Tec 6 vaporizer: named in the summary without a submission number
- (no number) Ohmeda Tec vaporizer - NAD variant: named in the summary without a submission number

## Indications for use
The Datex-Ohmeda D-Tec is an electronic vaporizer which delivers the anesthetic agent desflurane. It heats desflurane to maintain temperature and vapor pressure for consistent output. For added convenience and safety, the vaporizer has an LED display which indicates vaporizer status - no output, low agent, warm-up, operational and alarm battery low. The D-Tec attaches to the Dragerwerk interlocking manifold which allows the user to change vaporizer arrangement from case to case or move vaporizers from suite to suite without the need for tools.

Source page: https://510kreport.com/device/K990132
Methodology: https://510kreport.com/methodology