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Next Generation Portable Therapeutic Liquid Oxygen System

by Essex Cryogenics of Missouri, Inc.

510(k) K033000

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 NumberK033000 Date22 Mar 2004ClearedStatusActive

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  • Withdrawn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
BYJ
Device Class
Class II
Regulation
21 CFR Part 868.5655
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Portable Liquid-Oxygen Unit (FDA classification II) designed for therapeutic oxygen delivery. It operates as a low-pressure liquid oxygen storage and gaseous oxygen supply system, providing medical-grade oxygen in a compact, mobile format for clinical use.

The system delivers up to 17,200 liters of gaseous oxygen at a maximum flow rate of 66 liters per minute (50 psig) via six quick-disconnect outlet ports. Supplied as a reusable unit with an accessory kit, it is intended for use in anesthesiology settings and complies with FDA 510(k) clearance (K033000) under regulation 21 CFR 868.5655. No sterility or single-use designation is specified.

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