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
121–144 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 21, 2024
iSage Rx
K242066 · NDC
Amalgam Rx, Inc.
Chemistry · 37d
Cleared Aug 16, 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood...
K222126 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 760d
Cleared Aug 13, 2024
Shinetell Digital Pregnancy Test
K241978 · LCX
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 39d
Cleared Aug 09, 2024
CHOLESTEROL
K232404 · CHH
Medicon Hellas S.A
Chemistry · 365d
Cleared Aug 02, 2024
Innovita HCG Pregnancy Rapid Combo Test
K241919 · JHI
Innovita (Tangshan) Biological...
Chemistry · 32d
Cleared Jul 31, 2024
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 271d
Cleared Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800 · MRR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 26, 2024
Tandem Mobi Insulin Pump with interoperable technology
K241078 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 98d
Cleared Jul 26, 2024
Cell-Free DNA BCT
K231776 · QMA
Streck, Inc.
Chemistry · 406d
Cleared Jul 26, 2024
EasyStat 300
K220328 · CGA
Medica Corporation
Chemistry · 903d
Cleared Jul 25, 2024
Atellica® IM High-Sensitivity Troponin I (TnIH)
K241165 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 90d
Cleared Jul 22, 2024
Maverick Diagnostic System TC1000
K234091 · JLW
Genalyte, Inc.
Chemistry · 209d
Cleared Jul 02, 2024
Extended Reservoir
K241622 · LZG
Medtronic Minimed
Chemistry · 27d
Cleared Jun 21, 2024
MissLan® Early Detection Pregnancy Test Strip
K240643 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 106d
Cleared Jun 17, 2024
Elecsys Folate III
K233060 · CGN
Roche Diagnostics
Chemistry · 266d
Cleared Jun 07, 2024
Libre Rio Continuous Glucose Monitoring System
K233861 · SBH
Abbott Diabetes Care
Chemistry · 184d
Cleared Jun 06, 2024
WaveSense Jazz Blood Glucose Monitoring System
K241304 · NBW
Agamatrix
Chemistry · 28d
Cleared May 31, 2024
Distinct® Digital Pregnancy Test
K232715 · LCX
ACON Laboratories, Inc.
Chemistry · 269d
Cleared May 29, 2024
Lingo Glucose System
K233655 · SAF
Abbott
Chemistry · 197d
Cleared May 29, 2024
SmartAdjust(TM) technology
K232741 · QJI
Insulet Corporation
Chemistry · 265d
Cleared May 24, 2024
DEKA ACE Pump System
K241178 · QFG
Deka Research and Development
Chemistry · 25d
Cleared May 23, 2024
CamAPS FX
K232603 · QJI
Camdiab , Ltd.
Chemistry · 269d
Cleared May 08, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
K233581 · DHA
Ortho-Clinical Diagnostics
Chemistry · 183d
Cleared May 03, 2024
Access Intrinsic Factor Ab
K240800 · LIG
Beckman Coulter, Inc.
Chemistry · 39d