# K971923: Drager-Vapor 2000

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Sep 16, 1997 after 116 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940255 (1994). 1 ancestor in all.
4 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)
- K940255: Hyperinflation Bag System, Nutec, Inc. (1994) Summary page 1.

## Most influential descendants
- K042276: D-Vapor (2004), 2 descendants of its own
- K240375: V80 Anesthetic Vaporizer (V80) (2024), 0 descendants of its own
- K150167: V60 Anesthetic Vaporizer (2015), 0 descendants of its own
- K060331: Sigma Alpha Vaporizer (2006), 0 descendants of its own

## Recalls of this device
- Nov 24, 2025 · Class I · Z-0933-2026: A certain component of affected devices was not delivered within specification and contained impurities.
- Nov 24, 2025 · Class I · Z-0934-2026: A certain component of affected devices was not delivered within specification and contained impurities.

## Indications for use
fThe Dréger-Vapor 2000 (Vapor 2000) is a non-heared calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the smglc—agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or scvofluranc. The vaporizer ig not intended for use with desflurane, or for use within an anesthetic breathing system. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K971923
Methodology: https://510kreport.com/methodology