Non-Reusable Universal Nebulizer Filter

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Non-Reusable Universal Nebulizer Filte

510(k) Number

K823257 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ohio Absorber

  Class I

  FDA 510(k) K821144 Active Cleared 28 May 1982

• Ohio Disposable Tracheal Tube

  Class II

  FDA 510(k) K810763 Active Cleared 27 Mar 1981

• Ohio Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K822888 Active Cleared 16 Nov 1982

• Ohio 7000 Electronic Anesthesia Ventil.

  Class II

  FDA 510(k) K821376 Active Cleared 29 Jun 1982

• Ohio Free Flow Vacuum Regulator

  Class II

  FDA 510(k) K801169 Active Cleared 28 Jul 1980

• Oxygen Cannula

  Class I

  FDA 510(k) K770996 Active Cleared 29 Jun 1977

See all devices from Airco/Ohio Medical Products →

• What is the primary purpose of this device in clinical settings?

  This device is a bacterial filter for breathing circuits, designed to remove bacteria and contaminants from inhaled gases during anesthesia or respiratory therapy procedures. It ensures sterile airflow, which is critical in preventing infections when connected to respiratory systems.

• Is this filter meant for single-use or repeated use, and why?

  This filter is explicitly labeled as non-reusable and single-use. The manufacturer specifies it as a disposable component, meaning it should be discarded after a single use to maintain sterility and prevent cross-contamination in clinical settings.

• What regulatory pathway was followed for this device’s approval, and what does that mean for buyers?

  The device was cleared through the FDA 510(k) pathway (K823257), specifically under a Traditional 510(k) review. This means the manufacturer demonstrated that it is substantially equivalent to a legally marketed predicate device, adhering to CFR Title 21, regulation 868.5260. Buyers can rely on this clearance as evidence of compliance with FDA standards for bacterial filters in breathing circuits.

• Are there different sizes or models available for this filter, and how would I know which one to select?

  The provided data does not specify distinct sizes or models beyond its universal design for breathing circuits in anesthesiology. Since it’s labeled as a universal nebulizer filter, it should be compatible with standard breathing circuit setups. However, buyers should verify compatibility with their specific respiratory system setup or consult the manufacturer’s instructions for use to ensure proper fit and function.

• How should this filter be stored to maintain its effectiveness before use?

  While the data does not detail specific storage instructions, as a single-use, sterile disposable filter, it should be stored in a clean, dry environment away from direct sunlight, moisture, or extreme temperatures. The packaging should remain intact until use to preserve sterility. Always follow the manufacturer’s guidelines for optimal shelf life and handling.