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Oxicheck

by Caradyne, Ltd.

510(k) K023565

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 · Abbreviated NumberK023565 Date28 Mar 2003ClearedStatusActive

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  • Withdrawn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
CCL
Device Class
Class II
Regulation
21 CFR Part 868.1720
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.

The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture. It is a gaseous-phase oxygen analyzer classified under device class 2.

The device is supplied as a single-use, disposable analyzer and is not intended for use in breathing systems, patient monitoring, or continuous oxygen delivery confirmation. It is authorized under FDA 510(k) clearance K023565 and is intended for use in home care and similar settings.

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