Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled— 510(k) K252643
Substantially EquivalentTeleflex Medical Sdn. Bhd.
FDA 510(k) clearance K252643 for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled, Substantially Equivalent on 2026-05-15. Applicant: Teleflex Medical Sdn. Bhd.. Device class: 2.
Summary
Teleflex Medical's record covers two filters, the Iso-Gard Filter Straight and the Humid-Vent Filter Compact Angled. The product code is CAH, bacterial breathing-circuit filters.
Class II, 21 CFR 868.5260. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Anesthesiology as the classification panel.
Teleflex filed from Kamunting, Malaysia. The decision came 267 calendar days after receipt (August 21, 2025 to May 15, 2026).
Clearance details
- Applicant
- Teleflex Medical Sdn. Bhd.
- Product code
- Product code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kamunting, MY
Recent devices under product code CAH
view allMore clearances from Teleflex Medical Sdn. Bhd.
view allAdverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.