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Hi Flow Portable Liquid Oxygen Unit

by Minnesota Valley Engineering, Inc.

510(k) K875352

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 NumberK875352 Date29 Feb 1988ClearedStatusActive

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  • Withdrawn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.

The Hi Flow Portable Liquid Oxygen Unit is a Portable Liquid-Oxygen Unit (Device Class II), designed to deliver liquid oxygen in a portable, thermally insulated system. It is intended for use in medical settings where supplemental oxygen is required, particularly in anesthesiology applications. The device converts liquid oxygen into a gaseous form for inhalation therapy, ensuring a continuous and controlled oxygen supply.

This unit is supplied as a reusable medical device, regulated under FDA 510(k) clearance (K875352) and classified under regulation 868.5655. It operates in clinical environments such as operating rooms, emergency departments, or patient transport scenarios where portable oxygen delivery is necessary. The device is not single-use and requires proper maintenance and storage to ensure functionality and safety. No MRI safety or sterility specifications are noted in the regulatory data.

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