Bacterial and Viral Filter

Q: What is the product code of K895233?

The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.

FDA 510(k) K895233 · F.L.W. Plastics, Inc.

Substantially Equivalent

510(k) numberK895233

Submission

Device name: Bacterial and Viral Filter
Applicant: F.L.W. Plastics, Inc.
Columbus, IN, US
Received: August 21, 1989
Decision date: November 15, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CAH – Filter, Bacterial, Breathing-Circuit
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5260
Specialty: Anesthesiology

Other 510(k)s with product code CAH

510(k)	Device	Applicant	Decision
K252643	Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional	Teleflex Medical Sdn. Bhd.	05/15/2026SE
K251583	Ambu® Virobac II® Exhalation FilterCAH · Traditional	Ambu A/S	04/30/2026SE
K241339	Besmed Bacterial Filter and HMEFCAH · Traditional	Besmed Health Business Corp	11/14/2024SE
K222917	Breathing circuit bacterial/viral filterCAH · Traditional	Shaoxing Haitech Medical Products Co., Ltd.	02/15/2024SE
K230483	Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional	Passy-Muir, Inc.	09/16/2023SE
K223258	TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional	Intersurgical , Ltd.	06/15/2023SE
K221472	Filter and HME/FilterCAH · Traditional	Ningbo Huakun Medical Equipment Co., Ltd.	02/08/2023SE
K221836	Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional	Drägerwerk AG & Co. KGaA	12/07/2022SE
K221250	EasyOne FilterCAH · Traditional	Ndd Medizintechnik AG	11/22/2022SE
K210352	GGM Breathing Circuit Bacterial FilterCAH · Traditional	Great Group Medical Co, Ltd.	03/27/2022SE

More from Great Group Medical Co, Ltd.

510(k)	Device	Decision
K900291	Mass Spectrometry Monitoring Lines and ConnectorsCCK · Traditional	03/28/1990SE
K895357	Anethesia Breathing CircuitCAI · Traditional	10/19/1989SE
K895169	Manual Disposable Pulmonary ResuscitatorBTM · Traditional	10/13/1989SE

Questions and answers

When was Bacterial and Viral Filter cleared by the FDA?

Bacterial and Viral Filter (K895233) received a 510(k) decision of Substantially Equivalent on November 15, 1989, 86 days after the submission was received.

What is the product code of K895233?

The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.