Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

Q: What is the product code of K221836?

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) K221836 · Drägerwerk AG & Co. KGaA

Substantially Equivalent

510(k) numberK221836

Submission

Device name: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Applicant: Drägerwerk AG & Co. KGaA
Luebeck, DE
Received: June 23, 2022
Decision date: December 7, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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
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
K211286	Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerCAH · Traditional	Pall Corporation	11/16/2021SE

More from Pall Corporation

510(k)	Device	Decision
K251619	Babyleo TN500FMZ · Traditional	02/13/2026SE
K252827	IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott…DSA · Traditional	12/01/2025SE

Questions and answers

When was Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus cleared by the FDA?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (K221836) received a 510(k) decision of Substantially Equivalent on December 7, 2022, 167 days after the submission was received.

What is the product code of K221836?

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