Company ยท KR
I-Sens, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K260689 | CVS Advanced PLUS Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Aug 10, 2023 | K230625 | ReliOn Premier BLU Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Nov 23, 2022 | K222656 | LDE4 Lancing Device I-Sens, Inc., KR | QRL |
| Oct 5, 2021 | K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Sep 9, 2020 | K201551 | KetoSens BT Blood B-Ketone Monitoring System I-Sens, Inc., KR | JIN |
| Jan 24, 2020 | K192859 | CareSens S Clear BT Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Jan 17, 2020 | K193590 | CareSens S Fit BT Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Dec 13, 2019 | K192220 | ReliOn Premier Classic Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Nov 1, 2018 | K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Aug 31, 2018 | K180866 | CareSens S Fit Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Apr 13, 2018 | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System I-Sens, Inc., KR | JIN |
| Dec 13, 2017 | K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Oct 19, 2017 | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Dec 16, 2016 | K160742 | NoCoding1 Plus Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Aug 7, 2015 | K151164 | Assure Prism multi Blood Glucose Monitoring System I-Sens, Inc., KR | NBW |
| Dec 19, 2013 | K133346 | SMARTLOG DIABETES MANAGEMENT SOFTWARE I-Sens, Inc., KR | NBW |
| Nov 22, 2013 | K132288 | CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER I-Sens, Inc., KR | NBW |
| Aug 21, 2013 | K130696 | CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM I-Sens, Inc., KR | NBW |
| Aug 9, 2013 | K131419 | ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM I-Sens, Inc., KR | NBW |
| Sep 5, 2012 | K121654 | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION I-Sens, Inc., KR | CGA |
| Jul 10, 2012 | K121133 | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM I-Sens, Inc., KR | NBW |
| Jun 5, 2012 | K120759 | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION I-Sens, Inc., KR | CGA |
| May 3, 2012 | K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA I-Sens, Inc., KR | NBW |
| Oct 28, 2011 | K103278 | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION I-Sens, Inc., KR | CGA |
| Sep 27, 2011 | K103396 | COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION I-Sens, Inc. | NBW |
| Dec 21, 2010 | K100937 | PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE I-Sens, Inc., KR | NBW |
| Feb 10, 2009 | K083468 | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) I-Sens, Inc., KR | NBW |
| Oct 17, 2008 | K080923 | CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB I-Sens, Inc., KR | NBW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||