# K042276: D-Vapor

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Sep 23, 2004 after 31 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940255 (1994). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971923: Drager-Vapor 2000, Draeger Medical, Inc. (1997) Summary page 1.
- K000275: Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia, Datex-Ohmeda, Inc. (2000) Summary page 1.

## Most influential descendants
- K240375: V80 Anesthetic Vaporizer (V80) (2024), 0 descendants of its own
- K060331: Sigma Alpha Vaporizer (2006), 0 descendants of its own

## Recalls of this device
- Apr 21, 2016 · Class II · Z-1812-2016: Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing a

## Indications for use
The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K042276
Methodology: https://510kreport.com/methodology