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
673–696 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 06, 2017
POGO Automatic Blood Glucose Monitoring System
K162203 · NBW
Intuity Medical, Inc.
Chemistry · 244d
Cleared Apr 04, 2017
Beta-CrossLaps CalCheck 5
K170678 · JJX
Roche Diagnostics
Chemistry · 29d
Cleared Mar 31, 2017
Multichem IA Plus
K162530 · JJY
Techno-Path Manufacturing
Chemistry · 203d
Cleared Mar 21, 2017
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood...
K152534 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 564d
Cleared Mar 20, 2017
Direct LDL Cholesterol (LDL)
K161691 · MRR
Randox Laboratories Limited
Chemistry · 273d
Cleared Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG
Siemens Healthcare Diagnostics
Chemistry · 212d
Cleared Mar 09, 2017
BGM009 Plus Blood Glucose Monitoring System
K170267 · NBW
Apex BioTechnology Corp.
Chemistry · 41d
Cleared Mar 09, 2017
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
K170065 · JFM
Siemens Healthcare Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-,...
K161954 · JGS
Siemens Healthcare Diagnostics
Chemistry · 234d
Cleared Feb 17, 2017
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
K162281 · LCP
Sebia
Chemistry · 186d
Cleared Feb 16, 2017
TAP Blood Collection Device
K161521 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 259d
Cleared Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
K153561 · NBW
Andon Health Co, Ltd.
Chemistry · 430d
Cleared Feb 15, 2017
Abbott ARCHITECT Free T3
K170160 · JIT
Abbott Laboratories
Chemistry · 28d
Cleared Feb 09, 2017
UA-Cellular Complete
K170091 · JJW
Streck
Chemistry · 30d
Cleared Feb 09, 2017
PIVO
K163508 · JKA
Velano Vascular
Chemistry · 57d
Cleared Feb 08, 2017
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D...
K162840 · MRG
Roche Diagnostics
Chemistry · 120d
Not Cleared Feb 03, 2017
SEEKER System
DEN150035 · PQW
Baebies, Inc.
Chemistry · 548d
Cleared Jan 31, 2017
IDS-iSYS Intact PTHN
K161158 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 281d
Cleared Jan 23, 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
K162606 · JLW
Roche Diagnostics
Chemistry · 126d
Cleared Jan 19, 2017
UniStrip1 Generic Blood Glucose Test Strips
K162430 · NBW
Ok Biotech Co., Ltd.
Chemistry · 141d
Cleared Jan 19, 2017
Atellica CH Magnesium (Mg)
K162399 · JGJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 146d
Cleared Jan 18, 2017
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet,...
K162895 · MMI
Roche Diagnostics
Chemistry · 93d
Cleared Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
K163546 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 13, 2017
Lumipulse G FSH-N Calibrators
K163534 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d