# K031027: Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 26, 2003 after 86 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
Longest line of descent: 2 generations back to K892057 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942091: Ohmeda Tec 5 Vaporizer for Use with Sevoflurane, Ohmeda Medical (1995) Summary page 1.
- K892057: Ohmeda Tec 5 Continuous Flow Vaporizer, Ohmeda Medical (1989) Summary page 2.
- K012924: Datex-Ohmeda Tec 7 Anesthesia Vaporizer, Datex-Ohmeda, Inc. (2002) Summary page 1.

## Most influential descendants
- K172702: Tec 820, Tec 850 (2018), 0 descendants of its own

## Indications for use
The Datex-Ohnieda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.

Source page: https://510kreport.com/device/K031027
Methodology: https://510kreport.com/methodology