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
433–456 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 18, 2020
InPen Dose Calculator
K190487 · NDC
Companion Medical, Inc.
Chemistry · 355d
Cleared CT Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · NBW
Lifescan Europe GmbH
Chemistry · 60d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
K193103 · NQL
Perkinelmer, Inc.
Chemistry · 91d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 05, 2020
OptiScanner® 5000 Glucose Monitoring System
K192785 · LZF
Optiscan Biomedical Corporation
Chemistry · 128d
Cleared Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · QDK
Dexcom, Inc.
Chemistry · 30d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW
I-Sens, Inc.
Chemistry · 112d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · NBW
I-Sens, Inc.
Chemistry · 25d
Cleared Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
K192547 · DHA
Shenzhen New Industries Biomedical...
Chemistry · 122d
Cleared Jan 14, 2020
Oragene®•Dx
K192920 · OYJ
DNA Genotek, Inc.
Chemistry · 90d
Cleared Dec 20, 2019
ACTIVE® Free Testosterone RIA
K191350 · CDZ
Immunotech S.R.O.
Chemistry · 214d
Cleared Dec 19, 2019
Albumin BCP
K193001 · CJW
SENTINEL CH. SpA
Chemistry · 52d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW
I-Sens, Inc.
Chemistry · 120d
Not Cleared Dec 13, 2019
Control-IQ Technology
DEN190034 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 151d
Not Cleared Dec 12, 2019
GSP Neonatal Creatine Kinase - MM kit
DEN180056 · QJE
Perkinelmer, Inc.
Chemistry · 427d
Cleared Dec 11, 2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test...
K193132 · LCX
Hangzhou Clongene Biotech Co., Ltd.
Chemistry · 29d
Cleared Nov 25, 2019
ADVIA Centaur Cortisol (COR)
K192788 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2019
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test...
K192843 · LCX
Innovita (Tangshan) Biological...
Chemistry · 50d
Cleared Nov 08, 2019
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood...
K191286 · NBW
Ascensia Diabetes Care
Chemistry · 179d
Cleared Nov 06, 2019
GSP Neonatal Total Galactose kit
K190335 · JIA
Perkinelmer, Inc.
Chemistry · 265d