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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K252643
Device Name Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
Applicant
Teleflex Medical Sdn. Bhd.
Lot Pt. 2577
Jalan Perusahaan 4
Kamunting,  MY 34600
Applicant Contact Suguneswary Subramaniam
Correspondent
Teleflex Medical Sdn. Bhd.
Lot Pt. 2577
Jalan Perusahaan 4
Kamunting,  MY 34600
Correspondent Contact Suguneswary Subramaniam
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/21/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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