FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
1–24 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 24, 2026
Atellica CH Acetaminophen 2 (ACTM)
K261364 · LDP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
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 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 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 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