# K981773: Drager-Vapor 19.3

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Jul 6, 1998 after 47 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: 1 generation back to K771899 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771899: VAPOR 19, Draeger Medical, Inc. (1977) Summary page 1.
- K942055: Drager-Vapor 19.1, North American Grager (1995) Summary page 1.

## Indications for use
The Driger-Vapor 19.3 is a non-heated calibrated vaporizer to enrich the fresh gas flow of an anesthesia delivery system with a controlled anesthetic agent vapor. The Vapor 19.3 is indicated for use with enflurane, halothane, isoflurane, and sevoflurane. The Vapor 19.3 is not indicated for use with desflurane or in the breathing circuit of an anesthesia delivery system. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K981773
Methodology: https://510kreport.com/methodology