Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
25–48 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 23, 2026
TRUE METRIX Self Monitoring Blood Glucose System
K262116 · NBW
Trividia Health, Inc.
Chemistry · 30d
Cleared Jul 09, 2026
SmartGuard Technology
K261962 · QJI
Medtronic Minimed
Chemistry · 28d
Cleared Jun 26, 2026
i-STAT Crea cartridge with the i-STAT 1 System
K261039 · CGL
Abbott Point of Care, Inc.
Chemistry · 88d
Cleared Jun 17, 2026
twiist Automated Insulin Delivery (AID) System
K261672 · QFG
Deka Research and Development
Chemistry · 27d
Cleared Jun 16, 2026
Lipoprotein (a) Molarity Assay
K253069 · DFC
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared CT Jun 12, 2026
Stelo Glucose Biosensor System
K260935 · SBH
Dexcom, Inc.
Chemistry · 84d
Cleared Jun 12, 2026
cobas pulse blood glucose monitoring system
K252323 · PZI
Roche Diagnostics
Chemistry · 322d
Cleared Jun 11, 2026
i-STAT hs-TnI cartridge with the i-STAT Alinity System
K253051 · MMI
Abbott Point of Care, Inc.
Chemistry · 262d
Cleared Jun 08, 2026
Dexcom G7 Continuous Glucose Monitoring System
K261402 · QBJ
Dexcom, Inc.
Chemistry · 40d
Cleared Jun 03, 2026
iiSure Infusion Set
K261530 · FPA
Deka Research and Development
Chemistry · 26d
Cleared May 27, 2026
Glucommander
K254102 · NDC
Glytec, LLC
Chemistry · 159d
Cleared CT May 21, 2026
Stelo Glucose Biosensor System
K261359 · SAF
Dexcom, Inc.
Chemistry · 27d
Cleared May 01, 2026
EndoTool IV Cloud 1.0
K260910 · NDC
Glooko, Inc.
Chemistry · 43d
Cleared May 01, 2026
ABL90 FLEX PLUS System
K252488 · CGA
Radiometer Medicals Aps
Chemistry · 266d
Cleared May 01, 2026
ABL90 FLEX PLUS System
K252475 · JGS
Radiometer Medicals Aps
Chemistry · 267d
Cleared Apr 30, 2026
iLet ACE Pump
K253976 · QFG
Beta Bionics, Inc.
Chemistry · 139d
Cleared CT Apr 24, 2026
Control-IQ+ technology
K260429 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 73d
Cleared Apr 24, 2026
Elecsys Calcitonin
K252431 · JKR
Roche Diagnostics GmbH
Chemistry · 266d
Cleared Apr 15, 2026
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · JKA
Becton, Dickinson and Company
Chemistry · 89d
Cleared Apr 15, 2026
IDS-iSYS Total Testosterone
K252728 · CDZ
Immunodiagnostic Systems Limited
Chemistry · 230d
Cleared Apr 10, 2026
CeQur Simplicity™ On-Demand Insulin Delivery System
K252757 · OPP
Cequr SA
Chemistry · 224d
Cleared Apr 10, 2026
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™...
K252378 · JKA
Becton, Dickinson and Company
Chemistry · 254d
Cleared Apr 10, 2026
ABL90 FLEX PLUS System, safeCLINITUBES
K252207 · CHL
Radiometer Medicals Aps
Chemistry · 270d
Cleared Apr 08, 2026
Pivot Insulin Delivery System
K253534 · LZG
Modular Medical
Chemistry · 146d