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510(k) K221472

Filter and HME/Filter by Ningbo Huakun Medical Equipment Co., Ltd. — Product Code CAH

K221472 is an FDA 510(k) premarket notification submitted by Ningbo Huakun Medical Equipment Co., Ltd. for the device "Filter and HME/Filter". The FDA issued a decision of Substantially Equivalent on February 8, 2023. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2023
Date Received
May 20, 2022
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

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  • 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)
  • 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)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)

FDA data resources