FILTER— 510(k) K970102

Name: FDA 510(k) clearance K970102
Creator: U.S. Food and Drug Administration
Published: 1997-06-24

Substantially Equivalent

Promedic, Inc.

FDA 510(k) clearance K970102 for FILTER, Substantially Equivalent on 1997-06-24. Applicant: Promedic, Inc.. Device class: 2.

Clearance details

Applicant: Promedic, Inc.
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 1997-01-13
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAH

view all

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

More clearances from Promedic, Inc.

view all

K131889 — EUM 100PRO2014-04-23
K112318 — CLEARPATH 242012-06-29
K072756 — NON-IV ADAPTER FOR INFANT NG TUBE2007-12-19
K060497 — BABYAIR2006-07-11
K060842 — REVJET TURBO2006-06-21

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.