Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 42
- Latest Decision
- 2026-10-02
Clearances · page 1 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260689 | CVS Advanced PLUS Blood Glucose Monitoring System | I-Sens, Inc. | NBW | Class II | 2026-10-02 |
| K260468 | H100Plus Hemoglobin Testing System | Shenzhen Lifotronic Technology Co., Ltd. | PDJ | Class II | 2026-10-02 |
| K262215 | Profoject Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | JKA | Class II | 2026-09-25 |
| K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | JHI | Class II | 2026-09-22 |
| K262109 | Access NT-proBNP | Beckman Coulter, Inc. | NBC | Class II | 2026-09-21 |
| K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | SFU | Class II | 2026-09-18 |
| K261896 | iOS CamAPS FX | CamDiab | QJI | Class II | 2026-09-16 |
| K262763 | iLet Dosing Decision Software | Beta Bionics, Inc. | QJI | Class II | 2026-09-11 |
| K260001 | Mint ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2026-09-11 |
| K260062 | MODI System | DreaMed Diabetes, Ltd. | QRX | Class II | 2026-09-08 |
| K260613 | AMI Plasma Cartridge, AMI | Sequitur Health Corp. | JID | Class I | 2026-09-01 |
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2026-08-27 |
| DEN250049 | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | Abbott Diabetes Care | SJD | Class II | 2026-08-25 |
| K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | SBH | Class II | 2026-08-11 |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | NBW | Class II | 2026-07-23 |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | QJI | Class II | 2026-07-09 |
| K261461 | Omnipod 6 algorithm | Insulet Corporation | QJI | Class II | 2026-06-29 |
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CGL | Class II | 2026-06-26 |
| K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | QFG | Class II | 2026-06-17 |
| K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | SBH | Class II | 2026-06-12 |
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | PZI | Class II | 2026-06-12 |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | MMI | Class II | 2026-06-11 |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2026-06-08 |
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | JKA | Class II | 2026-06-02 |
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | SAF | Class II | 2026-05-21 |
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | CGA | Class II | 2026-05-01 |
| K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | JGS | Class II | 2026-05-01 |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2026-04-30 |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2026-04-24 |
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | JKR | Class II | 2026-04-24 |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company | JKA | Class II | 2026-04-15 |
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | CDZ | Class I | 2026-04-15 |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | JKA | Class II | 2026-04-10 |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | JKA | Class II | 2026-04-10 |
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | CHL | Class II | 2026-04-10 |
| K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | QBV | Class I | 2026-04-02 |
| K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | QBV | Class I | 2026-04-02 |
| K252169 | Access BNP II | Beckman Coulter, Inc. | NBC | Class II | 2026-03-24 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | JKA | Class II | 2026-03-13 |
| K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | QFG | Class II | 2026-03-12 |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | CIG | Class II | 2026-02-27 |
| K252619 | QSCHECK UISACR | Qstag, Inc. | JFY | Class II | 2026-02-20 |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | NBC | Class II | 2026-02-18 |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | CEM | Class II | 2026-02-12 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | CFR | Class II | 2026-02-12 |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2026-02-06 |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2026-02-03 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | QJI | Class II | 2026-02-03 |
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | SHB | Class II | 2026-01-21 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | QFG | Class II | 2026-01-15 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | QJI | Class II | 2026-01-14 |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | CGX | Class II | 2026-01-09 |
| K251157 | Core Metabolic | Truvian Health | CIX | Class II | 2026-01-09 |
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | PDJ | Class II | 2026-01-06 |
| K251091 | Lipids | Truvian Health | CHH | Class I | 2025-12-30 |
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | JMT | Class I | 2025-12-23 |
| K251152 | DBLG2 | Diabeloop | QJI | Class II | 2025-12-19 |
| K251074 | Tru Liver Health Test Panel | Truvian Health | CJE | Class II | 2025-12-19 |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2025-12-17 |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | QJI | Class II | 2025-12-03 |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | CGX | Class II | 2025-11-26 |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | QRX | Class II | 2025-11-18 |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2025-11-06 |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | JMT | Class I | 2025-10-30 |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | MMI | Class II | 2025-10-29 |
| K252357 | Glucose2 | Abbott Ireland | CFR | Class II | 2025-10-24 |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | NBW | Class II | 2025-10-10 |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | PDJ | Class II | 2025-10-03 |
| K252770 | iLet ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2025-09-29 |
| K251812 | Steripath® Flow Blood Collection System | Magnolia Medical Technologies | JKA | Class II | 2025-09-25 |
| K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | 2025-09-24 |
| DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | SFU | Class II | 2025-09-23 |
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | 2025-09-09 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | QJI | Class II | 2025-08-29 |
| K243965 | Origin | Nerv Technology Inc. (D.B.A.) Fluidai Medical | SFO | Class II | 2025-08-21 |
| K243483 | Access hsTnI | Beckman Coulter, Inc. | MMI | Class II | 2025-08-01 |
| K242505 | Elecsys Cortisol III | Roche Diagnostics | JFT | Class II | 2025-07-17 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | LCX | Class II | 2025-07-15 |
| K243207 | BD Vacutainer® Eclipse Blood Collection Needle | Becton, Dickinson and Company | JKA | Class II | 2025-07-03 |
| K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | QFG | Class II | 2025-07-01 |
| K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | PDJ | Class II | 2025-06-20 |
| K242870 | Access hsTnI | Beckman Coulter, Inc. | MMI | Class II | 2025-06-16 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | JKA | Class II | 2025-06-04 |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | JKA | Class II | 2025-05-23 |
| K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2025-05-21 |
| K242585 | Cystatin C | SENTINEL CH. SpA | NDY | Class II | 2025-05-16 |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CHL | Class II | 2025-05-02 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | JKA | Class II | 2025-04-30 |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics | JLW | Class II | 2025-04-25 |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2025-04-09 |
| K242209 | UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. | PTC | Class I | 2025-04-04 |
| K250930 | twiist system | Deka Research & Development Corp. | QFG | Class II | 2025-04-02 |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | JKA | Class II | 2025-03-21 |
| K250106 | Signos Glucose Monitoring System | Signos, Inc. | SAF | Class II | 2025-03-21 |
| K243922 | Revogene | Meridian Bioscience, Inc. | OOI | Class II | 2025-03-20 |
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | CGR | Class II | 2025-03-05 |
| K241586 | PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | JKA | Class II | 2025-02-27 |
| K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2025-02-24 |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | LCX | Class II | 2025-02-13 |
| K244042 | Calcium2 | Abbott Ireland | CJY | Class II | 2025-02-10 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.