| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | 2025-10-10 |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | 2025-01-30 |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-11-04 |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | 2024-10-08 |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 |
| K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | 2024-06-06 |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2024-02-23 |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-01-19 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
| K231476 | TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System | Sinocare, Inc. | 2023-12-01 |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023-08-10 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023-08-10 |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | 2023-06-28 |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-12-21 |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-11-04 |
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2022-10-07 |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | Hmd Biomedical, Inc. | 2022-08-29 |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-08-25 |
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | Bioland Technology, Ltd. | 2022-08-12 |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022-06-16 |
| K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2022-05-06 |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | 2022-04-06 |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-03-29 |
| K193406 | CardioChek Plus Test System; CardioChek Plus Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2022-02-26 |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021-12-23 |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | 2021-10-15 |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | I-Sens, Inc. | 2021-10-05 |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2021-09-15 |