Portable Liquid Oxygen Unit (Modification)

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K863978 ↗

FDA Product Code

BYJ

Device Class

Class II

Regulation

21 CFR Part 868.5655

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Penox Lift Chair

  Class II

  FDA 510(k) K851218 Active Cleared 21 Jun 1985

• Penox High Flow Manifold

  Class II

  FDA 510(k) K853775 Active Cleared 29 Nov 1985

• T-Handle Adapter, U-Handle & L Handler Adapter

  Class I

  FDA 510(k) K851215 Active Cleared 18 Jun 1985

• Fill Hose Safety Adapter

  Class I

  FDA 510(k) K851219 Active Cleared 18 Jun 1985

• Modified Penox Lift Chair

  Class II

  FDA 510(k) K862654 Active Cleared 18 Jul 1986

• Penox Dual Flow Minifold

  Class I

  FDA 510(k) K851217 Active Cleared 18 Jun 1985

See all devices from Penox Technologies, Inc. →

• What is the Portable Liquid Oxygen Unit (Modification) used for?

  The Portable Liquid Oxygen Unit (Modification) is designed to deliver liquid oxygen in a portable format, making it ideal for patients requiring supplemental oxygen outside of stationary hospital settings. It is particularly suited for anesthesiology and other clinical environments where mobility and a consistent oxygen supply are essential.

• Is the Portable Liquid Oxygen Unit (Modification) single-use or reusable?

  This device is supplied as a reusable unit. While it is not subject to specific sterility requirements beyond standard medical device hygiene protocols, it is intended for repeated use in clinical settings where oxygen therapy is administered.

• What regulatory pathway was followed for FDA clearance of this device?

  The Portable Liquid Oxygen Unit (Modification) received FDA 510(k) clearance through the traditional review pathway. It was determined to be substantially equivalent to a predicate device, ensuring compliance with FDA regulations under product code BYJ.

• Which clinical specialties primarily benefit from this device?

  This device is primarily intended for use in anesthesiology and other clinical specialties where oxygen therapy must be administered in mobile or non-stationary environments. Its portability and reliability make it particularly valuable in settings where traditional oxygen delivery systems are impractical.

• How is the Portable Liquid Oxygen Unit (Modification) regulated in the U.S.?

  The device is classified as a Class II medical device under FDA regulation 868.5655 and is authorized for use in the United States. It is regulated under product code BYJ and adheres to standard medical device hygiene protocols for reusable equipment.