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510(k) K252643

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled by Teleflex Medical Sdn. Bhd. — Product Code CAH

K252643 is an FDA 510(k) premarket notification submitted by Teleflex Medical Sdn. Bhd. for the device "Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled". The FDA issued a decision of Substantially Equivalent on May 15, 2026. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Teleflex Medical Sdn. Bhd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
August 21, 2025
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 Teleflex Medical Sdn. Bhd.

  • K252537 — Rusch SoftSimplastic Foley Catheters (January 20, 2026)

Other clearances for product code CAH

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

FDA data resources