TNI Clear-Guard 3 angled breathing filter (1545020)— 510(k) K223258

Name: FDA 510(k) clearance K223258
Creator: U.S. Food and Drug Administration
Published: 2023-06-15

Substantially Equivalent

Intersurgical , Ltd.

FDA 510(k) clearance K223258 for TNI Clear-Guard 3 angled breathing filter (1545020), Substantially Equivalent on 2023-06-15. Applicant: Intersurgical , Ltd.. Device class: 2.

Clearance details

Applicant: Intersurgical , Ltd.
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 2022-10-21
Decision date: 2023-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAH

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K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled2026-05-15
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

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.