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
49–72 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 19, 2025
Tru Liver Health Test Panel
K251074 · CJE
Truvian Health
Chemistry · 255d
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 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 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