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
505–528 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Feb 22, 2019
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use...
K181551 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 254d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183555 · JFY
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183549 · JGS
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183546 · CGA
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
Quo-Test A1c System
K180509 · LCP
Ekf Diagnostic GmbH
Chemistry · 354d
Cleared Feb 14, 2019
Dexcom G6 Continuous Glucose Monitoring System
K183206 · QBJ
Dexcom, Inc.
Chemistry · 87d
Not Cleared Feb 14, 2019
t:slim X2 insulin pump with interoperable technology
DEN180058 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 108d
Cleared Feb 13, 2019
Fenom Pro Nitric Oxide Test
K182874 · MXA
Spirosure, Inc.
Chemistry · 124d
Cleared Feb 12, 2019
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium...
K183375 · JJE
Horiba, Ltd.
Chemistry · 68d
Cleared Feb 08, 2019
Ammonia II
K183517 · JIF
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Jan 29, 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
K182521 · CDZ
Qualigen, Inc.
Chemistry · 138d
Cleared Jan 16, 2019
HbA1c Advanced
K182651 · PDJ
Beckman Coulter Ireland, Inc.
Chemistry · 114d
Cleared Jan 10, 2019
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette,...
K183097 · LCX
Weihai Kangzhou Biotechnology...
Chemistry · 64d
Cleared Dec 21, 2018
PTS Professional Chemistry Kit
K182781 · CGA
Polymer Technology Systems, Inc....
Chemistry · 81d
Cleared Dec 21, 2018
ADVIA Centaur Calcitonin (CALCT) assay
K182012 · JKR
Axis-Shield Diagnostics Limited
Chemistry · 147d
Not Cleared Dec 21, 2018
Miris Human Milk Analyzer
DEN180007 · QEI
Miris AB
Chemistry · 312d
Cleared Dec 19, 2018
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...
K173140 · NBW
Vivachek Laboratories, Inc.
Chemistry · 446d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593 · JIN
Apex BioTechnology Corp.
Chemistry · 89d
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d
Cleared Dec 10, 2018
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · JFY
Yd Diagnostics Corporation
Chemistry · 133d