Who else makes this device?

Name: Patient Circuit Kit
Brand: Patient Circuit Kit

Anesthesiology › TherapeuticVentilator, Continuous, Facility Use

Patient Circuit Kit

Catalogue number Patient Circuit Kit, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CBK
Manufacturer	City	Province	Registered as	Device types
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Beijing Aeonmed Co., Ltd.	Sanhe	Hebei	Contract manufacturer	7
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Patient Circuit Kit
Listed by	Corvent Medical Inc., United States
FDA product code	CBK
Device type	Ventilator, Continuous, Facility Use
Device class	Class 2
Regulation	21 CFR 868.5895
Establishment	Manufacturer
510(k)	K241135
Record published	2025-06-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Patient Circuit Kit
Catalogue number	Size	Per pack	Status
Patient Circuit Kit		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Puritan Bennett	Covidien LP	285
Newport	Newport Medical Instruments, Inc.	103
LTV	Vyaire Medical, Inc.	92
Ventilator, Continuous, Facility Use	Hans Rudolph, Inc.	66
Infant Flow SiPAP	Carefusion	62
Avea	Carefusion	57
Ventoux	Flight Medical Innovations Ltd.	48
Trilogy	Respironics Inc.	42
Avea™	Vyaire Medical, Inc.	39
Patient Circuits	Zoll Medical Corporation	38
Performatrak	Respironics Inc.	35
Bio-Med Devices, Inc.	BIO-MED Devices, Inc.	34

Showing 12 of 419. All products under Ventilator, Continuous, Facility Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241135	2024-11-13

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.