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Tec 7 Vap Hal 5% Easy-Fil En

by Datex-Ohmeda Inc.

Tec 7 Vap Hal 5% Easy-Fil En is a Class II device made by Datex-Ohmeda Inc., cleared under FDA 510(k) K012924 on 30 Jan 2002 and listed in FDA GUDID since 1 Jun 2016 (UDI-DI 00840682111003), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K012924

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682111003 UDI-DI Date1 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK012924 Date30 Jan 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012924 decided 30 Jan 2002 Active
  • FDA GUDID UDI-DI 00840682111003 listed 1 Jun 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1198-2018 FDA Class II initiated 4 Oct 2017

    Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Timeline

3 dated events

  1. Cleared FDA 510(k) K012924
  2. Listed FDA GUDID 00840682111003
  3. Recall initiated FDA recalls Z-1198-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tec 7
Generic name
Halothane anaesthesia vaporizer
Model / reference
VAP HAL 5% EASY-FIL EN
Primary DI / UDI-DI
00840682111003
510(k) Number
FDA product code
CAD
GMDN term
Halothane anaesthesia vaporizer
Device class
Class II
Regulation number
868.5880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Halothane anaesthesia vaporizer

Cleared under the same submission (K012924)

and 5 more cleared under K012924

Similar devices

Other devices filed under FDA product code CAD (VAPORIZER, ANESTHESIA, NON-HEATED).

Other devices from Datex-Ohmeda Inc.

See all devices from Datex-Ohmeda Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)