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
337–360 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 22, 2022
Creatinine2
K210452 · CGX
Abbott Ireland Diagnostics Division
Chemistry · 399d
Cleared Mar 18, 2022
Albumin BCP2
K203530 · CJW
Abbott Ireland Diagnostics Division
Chemistry · 471d
Cleared Mar 10, 2022
GLP systems Track
K213486 · JGS
Abbott Laboratories
Chemistry · 132d
Cleared Mar 10, 2022
One Step Pregnancy Test
K210341 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 398d
Cleared Feb 26, 2022
CardioChek Plus Test System
K193406 · NBW
Polymer Technology Systems, Inc....
Chemistry · 810d
Cleared Feb 18, 2022
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test...
K212447 · LCX
Hangzhou Sejoy Electronics &...
Chemistry · 197d
Cleared Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
K203234 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 469d
Cleared Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · JHI
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 451d
Cleared Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
K212648 · JHX
Ortho-Clinical Diagnostics
Chemistry · 158d
Cleared Jan 27, 2022
SmartAdjust technology
K203774 · QJI
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Omnipod 5 SmartBolus Calculator
K203772 · QRX
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Omnipod 5 ACE Pump (Pod)
K203768 · QFG
Insulet Corporation
Chemistry · 400d
Not Cleared Jan 21, 2022
POMC/PCSK1/LEPR CDx Panel
DEN200059 · QRV
Preventiongenetics, LLC
Chemistry · 490d
Cleared Dec 23, 2021
Contour® next GEN Blood Glucose Monitoring System
K193407 · NBW
Ascensia Diabetes Care
Chemistry · 745d
Cleared Dec 17, 2021
NObreath®
K203695 · MXA
Bedfont Scientific, Ltd.
Chemistry · 364d
Cleared Dec 13, 2021
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800...
K212221 · DHA
Diazyme Laboratories, Inc.
Chemistry · 150d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 23, 2021
Albumin BCG2
K203248 · CIX
Abbott Ireland Diagnostics Division
Chemistry · 384d
Cleared Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 237d
Cleared Nov 08, 2021
ST AIA-PACK BNP Assay
K211199 · NBC
Tosoh Bioscience, Inc.
Chemistry · 200d
Cleared Oct 28, 2021
EndoTool SubQ 2.1
K211160 · NDC
Monarch Medical Technologies, LLC
Chemistry · 192d
Cleared Oct 20, 2021
Piccolo Potassium Test System
K200865 · MZV
Abaxis, Inc.
Chemistry · 567d
Cleared Oct 15, 2021
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K201880 · NBW
Apex BioTechnology Corp.
Chemistry · 465d
Cleared Oct 05, 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood...
K201394 · NBW
I-Sens, Inc.
Chemistry · 496d