FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
313–336 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · NBW
Apex BioTechnology Corp.
Chemistry · 106d
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