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HYGEIA-5 Oxygen Concentrator

by Kedl Internation Limited 510(k)

Active United States

510(k) K081267

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081267 Date23 Sep 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Hygeia-5 Oxygen Concentrator is a portable oxygen generator classified under regulation number 868.5440 and product code CAW. It is a substantially equivalent device cleared through the FDA 510(k) process under traditional clearance, with decision date September 23, 2008. The device is designated for use in the anesthesiology medical specialty and is intended to provide supplemental oxygen.

It is supplied as a prescription device and is manufactured by Kedl Internation Limited. The device is classified as Class II and has been cleared for marketing in the United States. No information regarding sterility, single-use or reusable status, MRI safety, specific sizes, or storage conditions is provided in the supplied data.