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
385–408 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296 · CGS
Medtest DX
Chemistry · 455d
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 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