Cleared Traditional

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)

K964382 · Gibeck, Inc. · General Hospital
Apr 1997
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K964382 is an FDA 510(k) clearance for the HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402), a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 15, 1997, 162 days after receiving the submission on November 4, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K964382 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1996
Decision Date April 15, 1997
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

Similar Devices — CAH Filter, Bacterial, Breathing-circuit

All 199
Besmed Bacterial Filter and HMEF
K241339 · Besmed Health Business Corp · Nov 2024
Breathing circuit bacterial/viral filter
K222917 · Shaoxing Haitech Medical Products Co., Ltd. · Feb 2024
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · Passy-Muir, Inc. · Sep 2023
TNI Clear-Guard? 3 angled breathing filter (1545020)
K223258 · Intersurgical , Ltd. · Jun 2023
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · Dr?gerwerk AG & Co KGaA · Dec 2022