# K000275: Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Apr 12, 2000 after 72 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042276: D-Vapor (2004), 2 descendants of its own
- K240375: V80 Anesthetic Vaporizer (V80) (2024), 0 descendants of its own
- K140264: MADM (2015), 0 descendants of its own
- K060331: Sigma Alpha Vaporizer (2006), 0 descendants of its own

## Recalls of this device
- Nov 18, 2024 · Class II · Z-0814-2025: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Jul 29, 2013 · Class II · Z-2161-2013: GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual
- Sep 15, 2006 · Not classified · Z-0201-2007: There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.

Source page: https://510kreport.com/device/K000275
Methodology: https://510kreport.com/methodology