Skip to content

H.T.U. (Hyperbaric Therapy Unit)

by Hyox Systems C/O Mechidyne Systems, Inc.

510(k) K874107

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 NumberK874107 Date7 Dec 1987ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 868.5470
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The H.T.U. (Hyperbaric Therapy Unit) is a Class 2 hyperbaric chamber device used in anesthesiology. It is designed to provide hyperbaric therapy in a clinical setting.

The device is manufactured by Hyox Systems C/O Mechidyne Systems, Inc. and received FDA 510(k) clearance with product code CBF. It is a single unit with model number K874107 and is intended for use in a hospital or clinical environment.

Questions

AI-generated answers, 6 Oct 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 H.T.U. Hyperbaric Therapy Unit used for?

    The H.T.U. (Hyperbaric Therapy Unit) is designed to provide hyperbaric therapy in a clinical setting, specifically within the field of anesthesiology, as a Class 2 medical device intended for hospital or clinical environments.

  • Is the H.T.U. Hyperbaric Therapy Unit reusable or single-use?

    The H.T.U. is a single unit hyperbaric chamber device, indicating it is designed for repeated use in clinical settings rather than being a single-use disposable product, based on its classification as a durable medical equipment unit.

  • What model number and authorization does the H.T.U. Hyperbaric Therapy Unit have?

    The H.T.U. Hyperbaric Therapy Unit has model number K874107 and received FDA 510(k) clearance, with product code CBF and decision code SESE, confirming its substantially equivalent status under traditional review.