I-Sens, Inc. is one of 440 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
I-Sens, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CVS Advanced PLUS Blood Glucose Monitoring System, ReliOn Premier BLU Blood Glucose Monitoring System, LDE4 Lancing Device
28
Total
28
Cleared
0
Denied
I-Sens, Inc. has 28 FDA 510(k) cleared chemistry devices. Based in Seoul, KR.
Latest FDA clearance: Oct 2026. Active since 2008.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - I-Sens, Inc.
28 devices
Cleared
Oct 02, 2026
CVS Advanced PLUS Blood Glucose Monitoring System
Chemistry
213d
Cleared
Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
Chemistry
157d
Cleared
Nov 23, 2022
LDE4 Lancing Device
General & Plastic Surgery
82d
Cleared
Oct 05, 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood...
Chemistry
496d
Cleared
Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
Chemistry
92d
Cleared
Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
Chemistry
112d
Cleared
Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
Chemistry
25d
Cleared
Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
Chemistry
120d
Cleared
Nov 01, 2018
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine...
Chemistry
171d
Cleared
Aug 31, 2018
CareSens S Fit Blood Glucose Monitoring System
Chemistry
151d
Cleared
Apr 13, 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone...
Chemistry
422d
Cleared
Dec 13, 2017
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose...
Chemistry
208d