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Haolang Medical Usa Corporation: FDA-registered device maker in Clyde Hill, WA, United States, 7 510(k) clearances

Name: Haolang Medical Usa Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Haolang Medical Usa Corporation is registered with the FDA (registration 3016727301) in Clyde Hill, WA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 16, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016727301
Address: 8623 NE 26th Pl, Clyde Hill, WA, United States, 98004
Owner or operator: Haolang Medical USA Corporation (10065877)
Roles: Specification developer
First device listed: April 2, 2020
Registered through: 2026
Brand names listed: Arterial Catheter, Hemodialysis Catheter, NEEDLE-LESS VALVE, NEXUS MIDLINE CATHETER, ORION II CT CVC, Peripheral Inserted Central Catheter, Umbilical Vessels Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Hemodialysis, Implanted	MSD	2	Specification developer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Specification developer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Specification developer	accessdata.fda.gov
Catheter, Umbilical Artery	FOS	2	Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Specification developer	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
May 16, 2025	K241581	Hemodialysis Catheter	MSD	Unknown	Haolang Medical USA Corporation	accessdata.fda.gov
July 7, 2021	K201726	Arterial Catheter	DQY	Substantially Equivalent	Haolang Medical USA Corporation	accessdata.fda.gov
May 6, 2021	K201697	Umbilical Vessels Catheter	FOS	Substantially Equivalent	Haolang Medical USA Corporation	accessdata.fda.gov
August 20, 2014	K140270	NEXUS MIDLINE CT CATHETER	FOZ	Substantially Equivalent	Health Line International Corporation	accessdata.fda.gov
March 8, 2013	K130034	UNI-PICC	LJS	Substantially Equivalent	Health Line International Corporation	accessdata.fda.gov
May 18, 2012	K113622	ORION II CT CVC	FOZ	Substantially Equivalent	Health Line International Corporation (Hlic)	accessdata.fda.gov
May 4, 2012	K120548	HLIC NEEDLE-LESS VALVE	FPA	Substantially Equivalent	Health Line International Corporation	accessdata.fda.gov

Compare with other makers

Updated May 16, 2025. 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.