Skip to content

HTU3

by Hyox Systems, Ltd.

510(k) K984313

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984313 Date22 Oct 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
CBF
FDA applicant
Hyox Systems , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5470
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Htu3 is a Chamber, Hyperbaric, classified as a device class 2. It is substantially equivalent and has a regulation number of 868.5470.

The Htu3 is supplied by Hyox Systems, Ltd. and has an FDA 510K authorization. It is used in the medical specialty of Anesthesiology and has a product code of CBF. The device has a specific registration number and fei number, and is stored and shipped according to the manufacturer's instructions.

Questions

AI-generated answers, 23 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 HTU3 used for?

    The HTU3 is used in the medical specialty of Anesthesiology, indicating its application in procedures requiring hyperbaric conditions.

  • Is the HTU3 a single-use device?

    The device data does not specify if the HTU3 is for single-use or reuse, suggesting it may be reusable with proper maintenance and sterilization.

  • How is the HTU3 supplied and stored?

    The HTU3 is supplied by Hyox Systems, Ltd. and should be stored and shipped according to the manufacturer's instructions to ensure safety and efficacy.

  • What regulatory authorization does the HTU3 have?

    The HTU3 has an FDA 510K authorization, indicating it is substantially equivalent to a predicate device and has been cleared for marketing.