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
409–432 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 07, 2020
LZI Fentanyl II Enzyme Immunoassay
K201938 · DJG
Lin-Zhi International, Inc.
Chemistry · 25d
Cleared Aug 07, 2020
EndoTool IV System
K201619 · NDC
Monarch Medical Technologies, LLC
Chemistry · 53d
Not Cleared Aug 07, 2020
Cell-Free DNA BCT
DEN200001 · QMA
Streck, Inc.
Chemistry · 210d
Cleared Jul 28, 2020
Quantisal Oral Fluid Collection Device
K200801 · PJD
Immunalysis Corporation
Chemistry · 123d
Cleared CT Jun 16, 2020
Control-IQ Technology
K200467 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 111d
Cleared Jun 12, 2020
FreeStyle Libre 2 Flash Glucose Monitoring System
K193371 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 190d
Cleared Jun 05, 2020
epoc Blood Analysis System
K200107 · CHL
Epocal, Inc.
Chemistry · 140d
Cleared Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957 · JIN
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 228d
Cleared Jun 04, 2020
t:slim X2 Insulin Pump with Interoperable Technology
K201214 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 30d
Cleared Jun 04, 2020
Livongo Blood Glucose Monitoring System (BG1000)
K200277 · NBW
Livongo Health, Inc.
Chemistry · 121d
Cleared May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
K200509 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared May 06, 2020
LIAISON® Folate
K192586 · CGN
DiaSorin, Inc.
Chemistry · 230d
Cleared Apr 14, 2020
Stat Profile Prime Plus Analyzer System
K200403 · JGS
Nova Biomedical Corporation
Chemistry · 55d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · CHL
Abbott Point of Care, Inc.
Chemistry · 41d
Cleared Apr 07, 2020
BlueStar Rx
K193654 · MRZ
Welldoc, Inc.
Chemistry · 99d
Cleared Apr 06, 2020
Stat Profile Prime Plus Analyzer System
K200204 · GGZ
Nova Biomedical Corporation
Chemistry · 69d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240 · CHL
Siemens Healthcare Diagnostics, Inc.
Chemistry · 221d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Mar 26, 2020
Aina HbA1c Monitoring System 2
K192987 · LCP
Jana Care, Inc.
Chemistry · 153d
Cleared Mar 20, 2020
Bioland Blood Glucose Monitoring System
K191657 · NBW
Bioland Technology, Ltd.
Chemistry · 273d
Cleared Mar 17, 2020
EndoTool IV 1.10
K200443 · NDC
Monarch Medical Technologies, LLC
Chemistry · 22d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349 · CGA
Nova Biomedical Corporation
Chemistry · 30d
Cleared Feb 28, 2020
Basal-IQ Technology
K193483 · QJS
Tandem Diabetes Care, Inc.
Chemistry · 73d
Cleared Feb 27, 2020
Proov Test
K191462 · QKE
Mfb Fertility, Inc.
Chemistry · 269d