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
265–288 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 27, 2023
GEM Premier ChemSTAT
K223090 · CGA
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Jan 27, 2023
EasyStat 300
K211559 · CHL
Medica Corporation
Chemistry · 617d
Cleared Jan 27, 2023
Tacrolimus Assay Kit
K203833 · MLM
Shanghai Genext Medical Technology...
Chemistry · 758d
Cleared Jan 23, 2023
Tidepool Loop
K203689 · QJI
Tidepool Project
Chemistry · 767d
Cleared Jan 19, 2023
Access 25(OH) Vitamin D Total
K223503 · MRG
Beckman Coulter, Inc.
Chemistry · 58d
Cleared Jan 13, 2023
Access Testosterone
K223405 · CDZ
Beckman Coulter, Inc.
Chemistry · 65d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ
Dexcom, Inc.
Chemistry · 12d
Cleared Dec 29, 2022
Total Bilirubin2
K223324 · CIG
Abbott Ireland Diagnostics Division
Chemistry · 59d
Cleared Dec 27, 2022
Access Total ßhCG (5th IS)
K221990 · DHA
Beckman Coulter, Inc.
Chemistry · 174d
Cleared Dec 23, 2022
Access Vitamin B12
K223289 · CDD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Dec 22, 2022
Lp(a) Ultra
K211058 · DFC
SENTINEL CH. SpA
Chemistry · 622d
Cleared Dec 21, 2022
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · NBW
Apex BioTechnology Corp.
Chemistry · 148d
Cleared Dec 16, 2022
CardioPhase® hsCRP
K212559 · NQD
Siemens Healthcare Diagnostics...
Chemistry · 490d
Cleared Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
K213919 · QBJ
Dexcom, Inc.
Chemistry · 357d
Cleared Nov 30, 2022
MissLan™ Digital Pregnancy Rapid Test
K222305 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 121d
Cleared Nov 18, 2022
CONTOUR® NEXT GEN Blood Glucose Monitoring System
K223293 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 23d
Cleared Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · JLW
Beckman Coulter, Inc.
Chemistry · 196d
Cleared Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring...
K220421 · NBW
Apex BioTechnology Corp.
Chemistry · 263d
Cleared Oct 27, 2022
ORAcollect®•Dx
K212745 · OYJ
DNA Genotek, Inc.
Chemistry · 423d
Cleared Oct 26, 2022
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K221885 · QDJ
23AndMe, Inc.
Chemistry · 119d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549 · CGA
Nova Biomedical Corporation
Chemistry · 683d
Cleared Oct 07, 2022
SuperCheck Pro Blood Glucose Monitoring System
K213061 · NBW
Ok Biotech Co., Ltd.
Chemistry · 380d
Cleared Sep 21, 2022
Clearblue ® Early Pregnancy Test
K213379 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 343d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d