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
361–384 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared CT Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312 · NBC
Ortho-Clinical Diagnostics
Chemistry · 504d
Cleared Sep 28, 2021
Advisor Pro Platform
K210561 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 215d
Cleared Sep 21, 2021
Elecsys Troponin T Gen 5
K201441 · MMI
Roche Diagnostics
Chemistry · 477d
Cleared Sep 21, 2021
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine,...
K200898 · CIX
Medicon Hellas S.A
Chemistry · 536d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared CT Sep 08, 2021
BlueStar Rx
K203434 · NDC
Welldoc, Inc.
Chemistry · 289d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901 · MRG
Roche Diagnostics
Chemistry · 159d
Cleared Sep 01, 2021
EASYMAX Tag Self-Monitoring Blood Glucose System
K201258 · NBW
Eps Bio Technology Corp.
Chemistry · 478d
Cleared Aug 20, 2021
GEM Premier 5000
K203790 · CHL
Instrumentation Laboratory CO
Chemistry · 235d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB
Siemens Healthcare Diagnostics, Inc.
Chemistry · 603d
Cleared Aug 18, 2021
Elecsys HCG STAT
K203227 · DHA
Roche Diagnostics
Chemistry · 289d
Cleared Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · QDK
Dexcom, Inc.
Chemistry · 308d
Cleared Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · LZG
Insulet Corporation
Chemistry · 84d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · CGA
Abbott Point of Care, Inc.
Chemistry · 135d
Cleared Aug 13, 2021
Clearblue® Early Digital Pregnancy Test
K200913 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 494d
Cleared Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 120d
Cleared Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
K210687 · NBW
Ascensia Diabetes Care
Chemistry · 156d
Cleared Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
K203136 · NOE
Diazyme Laboratories, Inc.
Chemistry · 290d
Cleared Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 486d
Cleared Aug 04, 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine...
K203246 · LCX
Atlas Link Technology Co., Ltd.
Chemistry · 273d
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986 · CHL
Opti Medical Systems, Inc.
Chemistry · 474d
Cleared Jul 30, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K201761 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 396d
Cleared Jul 16, 2021
Medtronic Extended infusion set
K210544 · FPA
Unomedical A/S
Chemistry · 142d
Cleared Jul 15, 2021
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K201328 · QBJ
Dexcom, Inc.
Chemistry · 422d