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510(k) K050953

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE by Air Safety, Ltd. — Product Code CAH

K050953 is an FDA 510(k) premarket notification submitted by Air Safety, Ltd. for the device "AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE". The FDA issued a decision of Substantially Equivalent on June 29, 2005. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Air Safety, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2005
Date Received
April 15, 2005
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 Air Safety, Ltd.

  • K051712 — MODEL 2800 PFT FILTER (September 1, 2005)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • K033008 — AIR SAFETY HEPA AND NON-HEPA FILTERS (May 13, 2004)

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