Who else makes this device?

Name: Blood Circuit SET
Brand: Blood Circuit SET

Blood Circuit SET · Set, Tubing, Blood, with and without Anti-Regurgitation Valve → Gastroenterology & Urology

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

11recalls on this code

Who Else Makes It

Concentrated in Guangdong (3), Zhejiang (1), Jiangxi (1).

Chinese manufacturers registered for FDA product code FJK
Manufacturer	City	Province	Registered as	Device types
Ningbo Tianyi Medical Appliance Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	11
Guangzhou Kaiheng K&S Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	9
Jiangxi Sanxin Medtec Co., Ltd.	Nanchang	Jiangxi	Manufacturer	6
Bain Medical Equipment(Guangzhou) Co., Ltd.	Guangzhou	Guangdong	Manufacturer	3
Vital Healthcare (Guangzhou) Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	3

Record

Regulatory record for Blood Circuit SET
Listed by	Baxter Healthcare Corporation, United States
FDA product code	FJK
Device type	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class	Class 2
Regulation	21 CFR 876.5820
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K201809
Record published	2021-05-13
Record revised	2023-07-27 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 0 to 30 °C
Packaging	Case of 32
Sizes	Weight 110 g

Catalogue Numbers

Catalogue numbers for Blood Circuit SET
Catalogue number	Size	Status
101739	Weight 110 g	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ICU Medical	ICU Medical, Inc	58
Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET	Nipro Medical Corporation	12
Hemodialysis Bloodlines	B. Braun Medical Inc.	12
CombiSet	Fresenius Medical Care	11
Cartridge Blood Set	Gambro Renal Products S.A. DE C.V.	8
5008X	Fresenius Medical Care Renal Therapies Group, LLC	7
Sunder	Sunder Biomedical Tech. Co., Ltd.	6
Streamline Airless System Set with Locksite Needleless Access Sites	Medisystems Corp.	5
Tablo(R) Cartridge	Outset Medical, Inc.	5
NovaLine	Bain Medical Equipment(Guangzhou) Co., Ltd.	5
Medisystems Hemodialysis Blood Tubing Sets	Medisystems Corp.	4
Diapact®	B. Braun Medical Inc.	4

Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K934803	1993-12-17

Recalls

11 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2021-04-14	Class II	Under Investigation by firm	There is a potential leak between the venous patient connector and patient’s hemodialysis access.	17,487 units	2024-05-10
2020-12-30	Class II	Under Investigation by firm	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.	1460 devices
2020-12-30	Class II	Under Investigation by firm	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.	385 devices
2020-12-30	Class II	Under Investigation by firm	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.	211155 devices
2020-12-30	Class II	Under Investigation by firm	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.	7437480 units
2020-12-30	Class II	Under Investigation by firm	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.	25785 devices
2020-12-30	Class II	Under Investigation by firm	complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.	57825 devices
2020-04-17	Class II	Process control	Potential disconnection of tubing set.	4,065	2023-02-07
2020-04-17	Class II	Process control	Potential disconnection of tubing set.	53,895 units	2023-02-07
2020-04-17	Class II	Process control	Potential disconnection of tubing set.	2,361,885 units	2023-02-07
2020-04-17	Class II	Process control	Potential disconnection of tubing set.	19,800 units	2023-02-07

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.

Blood Circuit SET