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Jiangsu Kangbao Medical Equipment Co., Ltd: FDA-registered device maker in Yangzhou Jiangsu, China, 4 510(k) clearances

Name: Jiangsu Kangbao Medical Equipment Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jiangsu Kangbao Medical Equipment Co., Ltd is registered with the FDA (registration 3009742443) in Yangzhou Jiangsu, China. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009742443
Address: 78#, North SuZhong Road, Baoying 225800 Yangzhou, JIANGSU, Yangzhou Jiangsu, China, 225800
Owner or operator: Jiangsu Kangbao Medical Equipment Co., Ltd (10042938)
Roles: Contract manufacturer, Manufacturer
First device listed: August 1, 2014
Registered through: 2026
Brand names listed: NEEDLE COUNTER, ORAL DISPENSER, blood collection, blood collection needle, enteral syringe, enteral syringe with enfit connector, irrigation syringe, needle , syringe, syringe with needle , safety needle and more

Devices it lists

Device	Product code	Class	Role	Source
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 22, 2023	K232881	Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder	JKA	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.	accessdata.fda.gov
November 1, 2022	K221247	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle	MEG	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.	accessdata.fda.gov
November 15, 2021	K211329	Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	MEG	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.	accessdata.fda.gov
November 9, 2018	K182649	Enteral Feeding Syringes with Enfit Connectors	PNR	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.