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
145–168 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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
Cleared May 03, 2024
Emily's Care Nourish Test System (Model 1)
K234088 · QEI
Lactation Lab, Inc.
Chemistry · 133d