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510(k) K801803

MAINFLOW BACTERIA FILTER by Omnicon Medical Corp. — Product Code CAH

K801803 is an FDA 510(k) premarket notification submitted by Omnicon Medical Corp. for the device "MAINFLOW BACTERIA FILTER". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Omnicon Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
July 29, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Omnicon Medical Corp.

  • K823872 — EMERGENCY TRACHEOSTOMY KIT (January 21, 1983)
  • K820577 — ANESTHESIA BACTERIA FILTER (March 18, 1982)
  • K820576 — MAINFLOW BACTERIA FILTER (March 18, 1982)
  • K801804 — ANESTHESIA BACTERIA FILTER (August 13, 1980)
  • K772060 — PROTECT IV GARD (December 20, 1977)
  • K770136 — DISPOSABLE BACTERIA FILTER (February 14, 1977)
  • K770001 — AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (January 12, 1977)
  • K760819 — CONDUCTIVE ANESTHESIA BREATHING CIRCUIT (October 27, 1976)
  • K760149 — CONDUCTIVE ANESTHSIA BREATH. CIRCUIT (July 19, 1976)

Other clearances for product code CAH

  • K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (May 15, 2026)
  • K251583 — Ambu® Virobac II® Exhalation Filter (April 30, 2026)
  • K241339 — Besmed Bacterial Filter and HMEF (November 14, 2024)
  • K222917 — Breathing circuit bacterial/viral filter (February 15, 2024)
  • K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (September 16, 2023)
  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)

FDA data resources