I-SENS, Inc.
Seoul, KR
I-SENS, INC. appears in FDA device records in Seoul, KR. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for I-SENS, Inc. between 2008 and 2023. The busiest year on record is 2012, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 4 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K222656 | LDE4 Lancing Device | QRL | Substantially Equivalent | |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | JIN | Substantially Equivalent | |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | JIN | Substantially Equivalent | |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K160742 | NoCoding1 Plus Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K151164 | Assure Prism multi Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K133346 | SMARTLOG DIABETES MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K132288 | CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER | NBW | Substantially Equivalent | |
| K130696 | CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K131419 | ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K121654 | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION | CGA | Substantially Equivalent | |
| K121133 | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K120759 | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION | CGA | Substantially Equivalent | |
| K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | NBW | Substantially Equivalent | |
| K103278 | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION | CGA | Substantially Equivalent | |
| K103396 | COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION | NBW | Substantially Equivalent | |
| K100937 | PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K083468 | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) | NBW | Substantially Equivalent | |
| K080923 | CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005621222 | 3005621222 | I-SENS, INC. | 43, Banpo-daero 28-gil, Seocho-gu, SEOUL 06646 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain