FDA 510(k) clearance · back to tracker

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Teleflex Medical Sdn. Bhd. cleared K252643 on 2026-05-15, decision: substantially equivalent

K-number

K252643

Sponsor

Teleflex Medical Sdn. Bhd.

Device

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-15

Product code

CAH

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.5260

Official FDA record

Open K252643on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.