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
73–96 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505 · JFT
Roche Diagnostics
Chemistry · 329d
Cleared Jul 15, 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · LCX
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 102d
Cleared Jul 01, 2025
MiniMed 780G insulin pump
K251032 · QFG
Medtronic Minimed, Inc.
Chemistry · 89d
Cleared Jun 20, 2025
Medconn Glycated Hemoglobin Test system
K242911 · PDJ
Shanghai Medconn Medical Technology...
Chemistry · 269d
Cleared Jun 16, 2025
Access hsTnI
K242870 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared May 21, 2025
Control-IQ+ technology
K250798 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 68d
Cleared May 16, 2025
Cystatin C
K242585 · NDY
SENTINEL CH. SpA
Chemistry · 259d
Cleared May 09, 2025
SteadiSet Infusion Set
K242692 · FPA
Capillary Biomedical, LLC
Chemistry · 242d
Cleared May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · CHL
Abbott Point of Care, Inc.
Chemistry · 127d
Cleared Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · JLW
Siemens Healthcare Diagnostics
Chemistry · 158d
Cleared Apr 09, 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · QBJ
Dexcom, Inc.
Chemistry · 188d
Cleared Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
K242209 · PTC
Apex BioTechnology Corp.
Chemistry · 249d
Cleared Apr 02, 2025
twiist system
K250930 · QFG
Deka Research & Development Corp.
Chemistry · 5d
Cleared Mar 21, 2025
Signos Glucose Monitoring System
K250106 · SAF
Signos, Inc.
Chemistry · 65d
Cleared Mar 05, 2025
Access Cortisol
K242190 · CGR
Beckman Coulter, Inc.
Chemistry · 223d
Cleared Feb 24, 2025
Control-IQ+ technology
K243823 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 74d
Cleared Feb 13, 2025
FaStep Pregnancy Rapid Test Cassette
K250117 · LCX
Assure Tech., LLC
Chemistry · 28d
Cleared Feb 10, 2025
Calcium2
K244042 · CJY
Abbott Ireland
Chemistry · 42d
Cleared Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
K241453 · QWH
Roche Diagnostics
Chemistry · 261d
Cleared Jan 31, 2025
Synthgene Home Test HCG Test Strip
K242135 · LCX
Nanjing Synthgene Medical Technology...
Chemistry · 193d
Cleared Jan 30, 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · NBW
Guangdong Transtek Medical...
Chemistry · 125d
Cleared Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220 · DFC
Roche Diagnostics Operations
Chemistry · 268d
Cleared Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · LCX
Assure Tech., LLC
Chemistry · 57d