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
97–120 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 14, 2025
ABL90 FLEX PLUS System
K241037 · CEM
Radiometer Medicals Aps
Chemistry · 273d
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