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
121–144 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 10, 2025
Safecare Urinary Tract Infection Test
K242767 · JMT
Safecare Biotech (Hangzhou) Co., Ltd.
Chemistry · 119d
Cleared Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · MMI
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Dec 20, 2024
iHealth® Early Pregnancy Test
K241394 · LCX
Andon Health Co, Ltd.
Chemistry · 218d
Cleared Dec 13, 2024
ABL90 FLEX PLUS System
K240998 · CHL
Radiometer Medicals Aps
Chemistry · 246d
Cleared Dec 11, 2024
EndoTool IV (3.1)
K241088 · NDC
Monarch Medical Technologies
Chemistry · 236d
Cleared Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
K242685 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 89d
Cleared Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · LCP
Nova Biomedical Corporation
Chemistry · 931d
Cleared Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · CGX
Nova Biomedical Corporation
Chemistry · 881d
Cleared Nov 19, 2024
XPER Technology PREMIUM Pro Blood Glucose Monitoring System
K221349 · PZI
Taidoc Technology Corporation
Chemistry · 925d
Cleared Nov 13, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273 · OPP
Cequr SA
Chemistry · 28d
Cleared Nov 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · NDC
Medtronic Minimed
Chemistry · 60d
Cleared Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · NBW
Bionime Corporation
Chemistry · 243d
Cleared Oct 23, 2024
IDS-iSYS Free Testosterone
K240865 · CDZ
Immunodiagnostic Systems Limited
Chemistry · 209d
Cleared Oct 16, 2024
Alkaline Phosphatase
K240468 · CJE
Abbott Laboratories Diagnostics Division
Chemistry · 239d
Cleared Oct 11, 2024
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy...
K240242 · LCX
Anhui Deepblue Medical Technology...
Chemistry · 255d
Cleared Oct 08, 2024
Sejoy Blood Glucose Monitoring System
K240640 · NBW
Sejoy Biomedical Co., Ltd.
Chemistry · 216d
Cleared Sep 30, 2024
YSI 2900C Biochemistry Analyzer
K210933 · CGA
Ysi, Inc.
Chemistry · 1281d
Cleared Sep 16, 2024
Eversense 365 Continuous Glucose Monitoring (CGM) System
K241335 · SBA
Senseonics, Incorporated
Chemistry · 126d
Cleared Sep 12, 2024
Hipro Glycosylated Hemoglobin (HbA1c) Test System
K220999 · PDJ
Shijiazhuang Hipro Biotechnology Co.,...
Chemistry · 892d
Cleared Sep 04, 2024
Modular Medical MODD1 Insulin Delivery System
K240158 · LZG
Modular Medical, Inc.
Chemistry · 229d
Cleared Aug 30, 2024
embecta Insulin Delivery System
K234027 · QFG
Embecta Medical I, LLC
Chemistry · 254d
Cleared Aug 27, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K241787 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 67d
Cleared Aug 26, 2024
SmartAdjust™ Technology
K241777 · QJI
Insulet Corporation
Chemistry · 67d
Cleared Aug 21, 2024
iSage Rx
K242066 · NDC
Amalgam Rx, Inc.
Chemistry · 37d