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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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