Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Chemistry — Predicate Candidate Screening
13,051 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
149 daysmedian FDA review time
388 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | 2026-07-23 | 30 | 0 |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026-07-09 | 28 | 0 |
| K261461 | Omnipod 6 algorithm | Insulet Corporation | 2026-06-29 | 56 | 0 |
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2026-06-26 | 88 | 0 |
| K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | 2026-06-17 | 27 | 0 |
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2026-06-12 | 322 | 0 |
| K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026-06-12 | 84 | 0 |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | 2026-06-11 | 262 | 0 |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 | Dexcom, Inc. | 2026-06-08 | 40 | 0 |
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 | 264 | 0 |
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026-05-21 | 27 | 0 |
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026-05-01 | 266 | 0 |
| K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026-05-01 | 267 | 0 |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026-04-30 | 139 | 0 |
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026-04-24 | 266 | 0 |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026-04-24 | 73 | 0 |
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026-04-15 | 230 | 0 |
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 | 89 | 0 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® Min | Becton, Dickinson and Company | 2026-04-10 | 254 | 0 |
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026-04-10 | 270 | 0 |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutain | Becton, Dickinson and Company | 2026-04-10 | 245 | 0 |
| K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | 2026-04-02 | 405 | 0 |
| K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | 2026-04-02 | 405 | 0 |
| K252169 | Access BNP II | Beckman Coulter, Inc. | 2026-03-24 | 257 | 0 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® | Becton, Dickinson and Company | 2026-03-13 | 256 | 0 |
| K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026-03-12 | 108 | 0 |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 | 245 | 0 |
| K252619 | QSCHECK UISACR | Qstag, Inc. | 2026-02-20 | 185 | 0 |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | 2026-02-18 | 97 | 0 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integra | Roche Diagnostics | 2026-02-12 | 111 | 0 |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE ind | Roche Diagnostics | 2026-02-12 | 111 | 0 |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 | 262 | 0 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026-02-03 | 71 | 0 |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom | Dexcom, Inc. | 2026-02-03 | 71 | 0 |
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 2026-01-21 | 272 | 0 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin P | Medtronic Minimed, Inc. | 2026-01-15 | 97 | 0 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2026-01-14 | 58 | 0 |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026-01-09 | 179 | 0 |
| K251157 | Core Metabolic | Truvian Health | 2026-01-09 | 269 | 0 |
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 | 130 | 0 |
| K251091 | Lipids | Truvian Health | 2025-12-30 | 264 | 0 |
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025-12-23 | 194 | 0 |
| K251152 | DBLG2 | Diabeloop | 2025-12-19 | 249 | 0 |
| K251074 | Tru Liver Health Test Panel | Truvian Health | 2025-12-19 | 255 | 0 |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom | Dexcom, Inc. | 2025-12-17 | 23 | 0 |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025-12-03 | 176 | 0 |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025-11-26 | 236 | 0 |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025-11-18 | 75 | 0 |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-11-06 | 44 | 0 |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 | 73 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda