iGlucose Blood Glucose Monitoring System
FDA 510(k) K161790 · Bionime Corporation
510(k) numberK161790
Submission
- Device name
- iGlucose Blood Glucose Monitoring System
- Applicant
- Bionime Corporation
Taichung City, TW - Received
- June 29, 2016
- Decision date
- May 2, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | 11/04/2024SE |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | 01/19/2024SE |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceQRL · Traditional | 09/26/2022SE |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring…NBW · Traditional | 06/02/2019SE |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…NBW · Traditional | 08/17/2018SE |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System…NBW · Traditional | 06/19/2018SE |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest…NBW · Traditional | 07/06/2017SE |
| K140210 | Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720NBW · Traditional | 08/22/2014SE |
| K133003 | Rightest Control SolutionJJX · Traditional | 10/24/2013SE |
| K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System…NBW · Special | 01/25/2013SE |
Questions and answers
When was iGlucose Blood Glucose Monitoring System cleared by the FDA?
iGlucose Blood Glucose Monitoring System (K161790) received a 510(k) decision of Substantially Equivalent on May 2, 2017, 307 days after the submission was received.
What is the product code of K161790?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.