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Cyprane Tec 4 Continuous Flow Vapor

by Fraser Harlake, Inc. 510(k)

Active United States

510(k) K831427

Overview

This device is a vaporizer, anesthesia, non-heated, as defined in the device type and nomenclature. It is designed for the delivery of anesthetic vapors in a continuous flow system.

The Cyprane Tec 4 Continuous Flow Vapor is supplied by Fraser Harlake, Inc. and has received FDA 510(k) clearance under K831427. It is classified as a Class II medical device with product code CAD and is intended for use in anesthesiology settings.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831427 Date7 Jul 1983ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Cyprane Tec 4 Continuous Flow Vapor used for?

    The Cyprane Tec 4 Continuous Flow Vapor is designed for the delivery of anesthetic vapors in a continuous flow system and is intended for use in anesthesiology settings, as specified in its device description and intended use.

  • How is the Cyprane Tec 4 Continuous Flow Vapor supplied and by whom?

    The device is supplied by Fraser Harlake, Inc., as stated in the device data, and is distributed from their address in McHenry, Illinois, with no indication of sterile or single-use labeling in the provided information.

  • What regulatory pathway was used for the Cyprane Tec 4 Continuous Flow Vapor?

    The device received FDA 510(k) clearance under K831427, which is a traditional 510(k) submission demonstrating substantial equivalence to a predicate device, as indicated by the decision_description and clearance_type fields.

  • What is the classification and product code for the Cyprane Tec 4 Continuous Flow Vapor?

    The device is classified as a Class II medical device with product code CAD, as explicitly stated in the device data under product_code and device_class fields.

  • Is the Cyprane Tec 4 Continuous Flow Vapor a heated or non-heated vaporizer?

    The device is defined as a non-heated anesthesia vaporizer, as specified in the device name and description: 'Cyprane Tec 4 Continuous Flow Vapor' and 'vaporizer, anesthesia, non-heated'.