# I-Sens, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 28 (2008–2026): 28 510(k) clearances
- Product codes: NBW (22), CGA (3), JIN (2), QRL (1)
- 510(k) review time since 2016: median 171 days, against 190 for FDA's reviews in the same codes and years (8 of 13 faster)
- Predicates its devices cite: 22 (17 its own); citations of its devices by later devices: 25 (17 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lifescan, Inc.: 2 (https://510kreport.com/company/lifescan)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Nova Biomedical Corp.: 1 (https://510kreport.com/company/nova-biomedical)
- Agamatrix, Inc.: 1 (https://510kreport.com/company/agamatrix)

## Firms that cite its devices most
- Philosys, Inc.: 2 (https://510kreport.com/company/philosys)
- Hygeia, Ltd.: 2 (https://510kreport.com/company/hygeia)
- Mico Biomed Co., Ltd.: 2 (https://510kreport.com/company/mico-biomed)
- Genesis Health Technologies: 1 (https://510kreport.com/company/genesis-health-technologies)
- Vivachek Biotech (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/vivachek-biotech-hangzhou)

## Its most-cited devices
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color) (2009), cited by 12
- K170614: CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System (2017), cited by 3
- K160742: NoCoding1 Plus Blood Glucose Monitoring System (2016), cited by 2
- K080923: Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB (2008), cited by 2
- K103396: Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution (2011), cited by 1
- K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (2018), cited by 1

## Recent decisions
- K260689: CVS Advanced PLUS Blood Glucose Monitoring System (Oct 2, 2026)
- K230625: ReliOn Premier BLU Blood Glucose Monitoring System (Aug 10, 2023)
- K222656: LDE4 Lancing Device (Nov 23, 2022)
- K201394: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System (Oct 5, 2021)
- K201551: KetoSens BT Blood B-Ketone Monitoring System (Sep 9, 2020)
- K192859: CareSens S Clear BT Blood Glucose Monitoring System (Jan 24, 2020)
- K193590: CareSens S Fit BT Blood Glucose Monitoring System (Jan 17, 2020)
- K192220: ReliOn Premier Classic Blood Glucose Monitoring System (Dec 13, 2019)

Source page: https://510kreport.com/company/i-sens