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
553–576 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 04, 2018
NeoBase 2 Non-derivatized MSMS Kit
K173568 · NQL
Wallac Oy, Subsidiary of Perkinelmer,...
Chemistry · 288d
Cleared Aug 31, 2018
CareSens S Fit Blood Glucose Monitoring System
K180866 · NBW
I-Sens, Inc.
Chemistry · 151d
Cleared Aug 24, 2018
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · NBW
Eps Bio Technology Corp.
Chemistry · 24d
Cleared Aug 23, 2018
Stat Profile Prime Plus Analyzer System
K180186 · GGZ
Nova Biomedical Corporation
Chemistry · 212d
Cleared Aug 21, 2018
Confidence Blood Glucose Monitoring System
K173658 · NBW
Applied Biomedical, LLC
Chemistry · 265d
Cleared Aug 17, 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose...
K173638 · NBW
Bionime Corporation
Chemistry · 266d
Cleared Aug 15, 2018
Stat Profile Prime Plus Analyzer System
K180428 · JGS
Nova Biomedical Corporation
Chemistry · 180d
Cleared Aug 09, 2018
FORA GTel Blood Glucose Monitoring System
K173505 · NBW
Foracare, Inc.
Chemistry · 269d
Cleared Jul 20, 2018
Free Testosterone AccuBind ELISA Test System
K181017 · CDZ
Monobind, Inc.
Chemistry · 101d
Cleared Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 415d
Cleared Jul 18, 2018
NeoLSD MSMS kit
K173829 · PQW
Wallac Oy, A Subsidiary of Perkinelmer
Chemistry · 212d
Cleared Jul 18, 2018
DIP/U.S. Urine Analysis Test System
K173327 · JIL
Healthy.Io, Ltd.
Chemistry · 271d
Cleared Jul 17, 2018
Stat Profile Prime Plus Analyzer System
K173797 · CHL
Nova Biomedical Corporation
Chemistry · 215d
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 12, 2018
StatStrip Glucose Hospital Meter System
K181043 · PZI
Nova Biomedical Corporation
Chemistry · 84d
Cleared Jul 12, 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · NBW
Taidoc Technology Corporation
Chemistry · 241d
Cleared Jul 12, 2018
SEKURE HbA1c Assay
K173206 · PDJ
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 283d
Cleared Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
K171274 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 437d
Cleared Jul 10, 2018
Synermed ISE Reagents
K181201 · JGS
Infrared Laboratory Systems, LLC (Dba...
Chemistry · 64d
Cleared Jun 22, 2018
BioPlex 2200 25-OH Vitamin D Kit
K180577 · MRG
Bio-Rad Laboratories
Chemistry · 109d
Cleared Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
K173139 · NBW
Bionime Corporation
Chemistry · 263d
Cleared Jun 14, 2018
POGO Automatic Blood Glucose Monitoring System
K181316 · NBW
Intuity Medical, Inc.
Chemistry · 27d
Cleared Jun 14, 2018
Access hsTnl
K172787 · MMI
Beckman Coulter, Inc.
Chemistry · 272d
Cleared Jun 12, 2018
Access hs Tnl
K172783 · MMI
Beckman Coulter, Inc.
Chemistry · 270d