Skip to content

Technofil

by Technimeca Medic, Inc.

510(k) K953748

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 NumberK953748 Date25 Jan 1996ClearedStatusActive

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  • Withdrawn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.

Technofil is a non-heated anesthesia vaporizer. It is classified as a Class 2 medical device used within the field of anesthesiology.

This device is regulated under FDA 510(k) clearance K953748. It is manufactured by Technimeca Medic, Inc. and is identified by product code CAD.

Other devices from Technimeca Medic, Inc.

  • Techfil

    Class II