Who else makes this device?

Name: Filter CareStar 35 Plus
Brand: Filter CareStar 35 Plus

Anesthesiology › TherapeuticFilter, Bacterial, Breathing-Circuit

Filter CareStar 35 Plus

CareStar 35 Plus is a breathing-circuit filter used with ventilators or anesthesia machines. It filters inhaled and exhaled gases to reduce bacterial, viral and particulate contamination…

Registry build 21.09.26

CareStar 35 Plus is a breathing-circuit filter used with ventilators or anesthesia machines. It filters inhaled and exhaled gases to reduce bacterial, viral and particulate contamination within the breathing system.

The filter uses an electrostatic medium enclosed in a polypropylene housing. Standard conical connectors join it to the breathing circuit, and a luer-lock port allows gas sampling.

Filter Configuration

The medium contains polypropylene and synthetic fibers that provide the filtration function. CareStar Plus is the electrostatic filter range; selection within the range depends on the patient’s tidal volume and the breathing system. The filters are supplied nonsterile and are intended for single use for up to 24 hours by trained medical personnel.

15manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAH
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Amsino Medical (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	22
Zhejiang Haisheng Medical Device Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	21
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
Sunmed AP, Ltd., Warehouse NO. 2	Zhuhai	Guangdong	Contract manufacturer	16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	12
GVS Technology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	5
Changshu Rozer Sterilization Technology Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	43
Rozer Sterilization Technology Shuyang Company Limited	Shuyang	Jiangsu	Contract manufacturer	33

Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit

Record

Regulatory record for Filter CareStar 35 Plus
Listed by	Drägerwerk AG & Co. KGaA, Germany
FDA product code	CAH
Device type	Filter, Bacterial, Breathing-Circuit
Device class	Class 2
Regulation	21 CFR 868.5260
510(k)	K221836
Record published	2023-01-09

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Filter CareStar 35 Plus
Catalogue number	Size	Status
MP05755		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	405
Pulmoguard	S D I Diagnostics Inc	203
Cardinal Health	Cardinal Health 200, LLC	131
DAR	Covidien LP	110
Portex	ICU Medical, Inc	108
Vital Signs™	SunMed Group Holdings, LLC	78
Pentair	Pentair Filtration Solutions	68
Disposable Anesthesia Circuits	Westmed, Inc.	68
AirLife™	AirLife Finland Oy	43
Ventlab	Ventlab, LLC	40
VBMax	A-M Systems	39
Vital Signs™	AirLife Finland Oy	38

Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K221836	2022-12-07

Recalls Naming This Product

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Filter CareStar 35 Plus
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Draeger, Inc.	510(k) number	2025-06-16	Class I	Process control	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.	669,838 units
Draeger, Inc.	510(k) number	2025-06-16	Class I	Process control	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.	9,885,139 units
Draeger, Inc.	510(k) number	2025-06-16	Class I	Process control	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.	1,019,782 units
Draeger, Inc.	510(k) number	2025-06-16	Class I	Process control	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.	374,700 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.