Skip to content

Drager-Vapor 19.1

by North American Grager

510(k) K942055

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942055 Date27 Jan 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAD
Device Class
Class II
Regulation
21 CFR Part 868.5880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Drager-Vapor 19.1 is an anesthesia vaporizer designed for the administration of anesthetic agents. It features a key-index fill and drain system and is compatible with various anesthetic agents including enflurane, isoflurane, and sevoflurane.

This device is a non-heated anesthesia vaporizer with a device class of 2. It is manufactured by North American Grager and has FDA 510K clearance with product code CAD. The vaporizer is supplied in various sizes and models as specified by the manufacturer.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Drager-Vapor 19.1 used for?

    The Drager-Vapor 19.1 is an anesthesia vaporizer designed for the administration of anesthetic agents including enflurane, isoflurane, and sevoflurane. It features a key-index fill and drain system to ensure proper agent handling.

  • How is the Drager-Vapor 19.1 supplied?

    The vaporizer is supplied in various sizes and models as specified by the manufacturer, North American Grager. Each model maintains the same core functionality but may differ in specifications to accommodate different clinical needs.

  • What is the regulatory status of the Drager-Vapor 19.1?

    The Drager-Vapor 19.1 has FDA 510K clearance with product code CAD. It is classified as a non-heated anesthesia vaporizer with device class 2, indicating it requires controls to ensure safety and effectiveness.

  • Can the Drager-Vapor 19.1 be reused or is it single-use?

    The device is designed for multiple uses rather than single-use. As an anesthesia vaporizer, it is built to withstand repeated clinical applications with proper maintenance and cleaning according to manufacturer guidelines.