Data / Medical devices / South Korea / Bistos co., ltd.

Bistos co., ltd.: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 11 510(k) clearances

Name: Bistos co., ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bistos co., ltd. is registered with the FDA (registration 3006179052) in Yongin-si Gyeonggi, South Korea. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006179052
Address: 522, Geumeo-ro, Pogok-eup, Cheoin-gu, Yongin-si Gyeonggi, South Korea, 17030
Owner or operator: Bistos Co., Ltd. (10023402)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: November 22, 2007
Registered through: 2026
Brand names listed: BT-1000, BT-200, BT-200T, BT-200V, BT-220C Prenatal Monitoring System, BT-220L Prenatal Monitoring System, BT-300, BT-350 and more

Devices it lists

Device	Product code	Class	Role	Source
Colposcope (And Colpomicroscope)	HEX	2	Contract manufacturer	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transcutaneous Nerve Stimulator For Adhd	QGL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Obstetric	HGL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Unit, Neonatal Phototherapy	LBI	2	Complaint file establishment, 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
September 25, 2025	K251512	Hi bebe super (BT-150B)	HGX	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
August 28, 2024	K232991	BT-1000	QGL	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
May 28, 2021	K210289	Infant Phototherapy Equipment	LBI	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
September 1, 2016	K160274	Hi bebe plus	HGX	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
July 9, 2015	K142799	Model BT-220L and BT-220C	HGM	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
March 20, 2015	K142332	BT-400	LBI	Substantially Equivalent	Bio-Med USA	accessdata.fda.gov
July 3, 2014	K132543	INFANT INCUBATOR	FMZ	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
August 2, 2012	K121267	BT-200V VASCULAR DOPPLER	HGM	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
May 13, 2011	K103545	BT-350	HGM	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
June 7, 2010	K100885	FETAL MONITOR MODEL: BT-200T	HGM	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
October 4, 2005	K052190	FETAL MONITOR, MODELS BT-300 AND BT-200	HGM	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 25, 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.