FDA.reportPublic FDA data

I-SENS USA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087803883008780388I-SENS USA, INC.1Y2026-01-013545 Lomita Blvd., Unit D Torrance CA US 90505

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1247631224567074K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
1247631484562245K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesFMI2022-05-25
1247631962510585K201551KetoSens BT Blood B-Ketone Monitoring SystemJIN2020-09-09
1247631612191364K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemNBW2021-10-05
1247632066412408K193590CareSens S Fit BT Blood Glucose Monitoring SystemNBW2020-01-17
1247631744601807K192859CareSens S Clear BT Blood Glucose Monitoring SystemNBW2020-01-24
1247631909770462K180866CareSens S Fit Blood Glucose Monitoring SystemNBW2018-08-31
1247631351722652K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
1247631295518976K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
1247631560173115K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN2018-04-13
1247631992233399K160742NoCoding1 Plus Blood Glucose Monitoring SystemNBW2016-12-16
1247631783466985K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
1247631444707629K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
1247631268557870K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
1247631620520919K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
1247631102003830

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW102021-10-05
JIN22020-09-09
QRL12022-07-06
FMI12022-05-25
DXN12013-06-19