Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled— 510(k) K252643

Name: FDA 510(k) clearance K252643
Creator: U.S. Food and Drug Administration
Published: 2026-05-15

Substantially Equivalent

Teleflex 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.

Clearance details

Applicant: Teleflex Medical Sdn. Bhd.
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 2025-08-21
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamunting, MY

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAH

view all

K251583 — Ambu® Virobac II® Exhalation Filter2026-04-30
K241339 — Besmed Bacterial Filter and HMEF2024-11-14
K222917 — Breathing circuit bacterial/viral filter2024-02-15
K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)2023-09-16
K223258 — TNI Clear-Guard 3 angled breathing filter (1545020)2023-06-15

More clearances from Teleflex Medical Sdn. Bhd.

view all

K262056 — Rusch Latex Gold Foley Catheter2026-08-05
K252537 — Rusch SoftSimplastic Foley Catheters2026-01-20

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.