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Beijing Hangtian Kadi Technology R&D Institute: FDA-registered device maker in Beijing, China, 2 510(k) clearances

Name: Beijing Hangtian Kadi Technology R&D Institute FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beijing Hangtian Kadi Technology R&D Institute is registered with the FDA (registration 3010701807) in Beijing, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010701807
Address: 3rd floor, No.23, Longtai Road Juigong Town Daxing District, Beijing, China, 100076
Owner or operator: Beijing HangTian KADI Technology R&D Institute (10046217)
Roles: Manufacturer
First device listed: November 26, 2025
Registered through: 2026
Brand names listed: HKTD Disposable Suture Holder, HTKD Blower/Mister, HTKD Heart Stabilizer, Specimen Retrieval Bag, Uterine Manipulators

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Manipulator/Injector, Uterine	LKF	2	Manufacturer	accessdata.fda.gov
Holder, Heart-Valve, Prosthesis	DTJ	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Stabilizer, Heart	MWS	1	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
June 26, 2018	K172846	Uterine Manipulator	LKF	Substantially Equivalent	Beijing Hangtian Kadi Technology R&D Institute	accessdata.fda.gov
February 1, 2018	K172789	Specimen Retrieval Bag	GCJ	Substantially Equivalent	Beijing Hangtian Kadi Technology R&D Institute	accessdata.fda.gov

Compare with other makers

Updated June 26, 2018. 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.