Bistos Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bistos Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Hi bebe super (BT-150B), BT-1000, Infant Phototherapy Equipment
11
Total
11
Cleared
0
Denied
Bistos Co., Ltd. has 11 FDA 510(k) cleared medical devices. Based in Flintville, US.
Latest FDA clearance: Sep 2025. Active since 2005. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Bistos Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mtechgroup and Regulatory Technology Services, LLC.
FDA 510(k) Regulatory Record - Bistos Co., Ltd.
11 devices
Cleared
Sep 25, 2025
Hi bebe super (BT-150B)
Obstetrics & Gynecology
132d
Cleared
Aug 28, 2024
BT-1000
Neurology
341d
Cleared
May 28, 2021
Infant Phototherapy Equipment
General Hospital
115d
Cleared
Feb 10, 2021
Hi bebe super (Models BT-150S and BT-150L)
Obstetrics & Gynecology
331d
Cleared
Sep 01, 2016
Hi bebe plus
Obstetrics & Gynecology
212d
Cleared
Jul 09, 2015
Model BT-220L and BT-220C
Obstetrics & Gynecology
283d
Cleared
Jul 03, 2014
INFANT INCUBATOR
General Hospital
324d
Cleared
Aug 02, 2012
BT-200V VASCULAR DOPPLER
Radiology
98d
Cleared
May 13, 2011
BT-350
Obstetrics & Gynecology
162d
Cleared
Jun 07, 2010
FETAL MONITOR MODEL: BT-200T
Radiology
69d
Cleared
Oct 04, 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
Obstetrics & Gynecology
54d