# K172702: Tec 820, Tec 850

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jan 4, 2018 after 119 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K892057 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031027: Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane), Datex-Ohmeda, Inc. (2003) Summary page 4.
- K012924: Datex-Ohmeda Tec 7 Anesthesia Vaporizer, Datex-Ohmeda, Inc. (2002) Summary page 4.

## Recalls of this device
- Nov 18, 2024 · Class II · Z-0815-2025: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Nov 18, 2024 · Class II · Z-0818-2025: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Nov 18, 2024 · Class II · Z-0816-2025: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Nov 18, 2024 · Class II · Z-0817-2025: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

## Indications for use
The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. 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 for use only with General Electric's Selectatec Series Manifolds.

Source page: https://510kreport.com/device/K172702
Methodology: https://510kreport.com/methodology