Mainflow Bacteria Filter

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

510(k) Number

K820576 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Anesthesia Bacteria Filter

  Class II

  FDA 510(k) K820577 Active Cleared 18 Mar 1982

• Disposable Bacteria Filter

  Class II

  FDA 510(k) K770136 Active Cleared 14 Feb 1977

• Emergency Tracheostomy Kit

  Class I

  FDA 510(k) K823872 Active Cleared 21 Jan 1983

• Protect IV Gard

  Class I

  FDA 510(k) K772060 Active Cleared 20 Dec 1977

• Mainflow Bacteria Filter

  Class II

  FDA 510(k) K801803 Active Cleared 13 Aug 1980

• Conductive Anesthsia Breath. Circuit

  Class I

  FDA 510(k) K760149 Active Cleared 19 Jul 1976

See all devices from Omnicon Medical Corp. →

• What is the Mainflow Bacteria Filter used for?

  The Mainflow Bacteria Filter is designed to remove microbiological and particulate matter from gases in the breathing circuit, intended for use in medical settings where filtration of breathing circuit gases is required.

• How is the Mainflow Bacteria Filter supplied?

  The device is supplied individually packaged and is available in various sizes to accommodate different clinical needs and breathing circuit configurations.

• What is the filtration efficiency of the Mainflow Bacteria Filter?

  The Mainflow Bacteria Filter has a bacterial efficiency of 99.9992% and a viral efficiency of 99.990%, with a dead space of 45.9 mL and flow resistance of approximately 1.8 cm H2O at 60 LPM.

• Is the Mainflow Bacteria Filter single-use or reusable?

  The device is supplied individually packaged, but the description does not specify whether it is designed for single-use or multiple uses, which would be determined by the manufacturer's instructions for use.

• What is the regulatory status of the Mainflow Bacteria Filter?

  The Mainflow Bacteria Filter is authorized under FDA 510(k) clearance K820576 with product code CAH, classified as substantially equivalent to predicate devices in the anesthesiology medical specialty.