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
97–120 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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 CT 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 CT 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
Cleared CT Jan 14, 2025
ABL90 FLEX PLUS System
K241037 · CEM
Radiometer Medicals Aps
Chemistry · 273d