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510(k) K841581

UNIFILTER ANESTHESIA & RESPIRATORY FILT by Dupaco, Inc. — Product Code CAH

K841581 is an FDA 510(k) premarket notification submitted by Dupaco, Inc. for the device "UNIFILTER ANESTHESIA & RESPIRATORY FILT". The FDA issued a decision of Substantially Equivalent on April 30, 1984. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Dupaco, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1984
Date Received
April 17, 1984
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 Dupaco, Inc.

  • K150518 — Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and To (June 29, 2015)
  • K830395 — PEEPER (March 11, 1983)
  • K821434 — EKG (ECG) ELECTRODES (July 30, 1982)
  • K770084 — OPERATING ROOM VENTILATOR (February 23, 1977)

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