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
73–96 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 17, 2025
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day...
K253710 · QBJ
Dexcom, Inc.
Chemistry · 23d
Cleared Dec 03, 2025
Omnipod 5 algorithm
K251779 · QJI
Insulet Corporation
Chemistry · 176d
Cleared Nov 26, 2025
Fenom Flo™ FeNO Monitoring System
K251674 · MXA
Mgc Diagnostics Corporation
Chemistry · 180d
Cleared Nov 26, 2025
Tru Kidney Health Test Panel
K251058 · CGX
Truvian Health
Chemistry · 236d
Cleared Nov 18, 2025
Dexcom Smart Basal
K252818 · QRX
Dexcom, Inc.
Chemistry · 75d
Cleared Nov 06, 2025
Tandem Mobi insulin pump with interoperable technology
K253074 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 44d
Cleared Oct 30, 2025
AllTest Urinary Tract Infection Test
K252607 · JMT
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 73d
Cleared Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
K252393 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 24, 2025
Glucose2
K252357 · CFR
Abbott Ireland
Chemistry · 87d
Cleared Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · NBW
ACON Laboratories, Inc.
Chemistry · 270d
Cleared Oct 03, 2025
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
K250073 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 266d
Cleared CT Sep 29, 2025
iLet ACE Pump
K252770 · QFG
Beta Bionics, Inc.
Chemistry · 27d
Cleared Sep 24, 2025
t:slim X2 insulin pump with interoperable technology
K250792 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 194d
Not Cleared Sep 23, 2025
Biolinq Shine Autonomous Time-in-Range Microsensor
DEN240080 · SFU
Biolinq Incorporated
Chemistry · 270d
Cleared Sep 11, 2025
Vivatmo pro-S
K243926 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 265d
Cleared Sep 09, 2025
MissLan® Early Detection Digital Pregnancy Test
K251040 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 159d
Cleared CT Aug 29, 2025
SmartGuard technology
K251217 · QJI
Medtronic Minimed, Inc.
Chemistry · 130d
Cleared Aug 21, 2025
Origin™
K243965 · SFO
Nerv Technology Inc. (D.B.A.) Fluidai...
Chemistry · 241d
Cleared Aug 20, 2025
T1D1
K252104 · NDC
Comerge AG
Chemistry · 48d
Cleared Aug 06, 2025
SteadiSet infusion set
K251854 · FPA
Tandem Diabetes Care
Chemistry · 50d
Cleared Aug 01, 2025
Sparta Infusion Set for Insulin
K243841 · FPA
Deka Research and Development
Chemistry · 231d
Cleared Aug 01, 2025
Access hsTnI
K243483 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Aug 01, 2025
Diazyme Colorimetric Lithium Assay
K243462 · NDW
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505 · JFT
Roche Diagnostics
Chemistry · 329d