Clearance Summary
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled received FDA 510(k) clearance under submission number K252643, sponsored by Teleflex Medical Sdn. Bhd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-05-15.
- Submission: K252643
- Applicant / Sponsor: Teleflex Medical Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5260
- Decision date: 2026-05-15
Classification & Regulation
This clearance is catalogued under FDA product code CAH and 21 CFR 868.5260, within the Anesthesiology review panel as a Class II device.