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
217–240 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · JGS
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Oct 18, 2023
Omnipod 5 ACE Pump
K231826 · QFG
Insulet Corporation
Chemistry · 119d
Cleared Oct 18, 2023
SmartBolus Calculator
K231824 · QRX
Insulet Corporation
Chemistry · 119d
Cleared Oct 13, 2023
Macro & Micro-Test HCG Pregnancy Test Midstream
K230741 · LCX
Jiangsu Macro & Micro-Test Med-Tech...
Chemistry · 210d
Cleared Oct 05, 2023
Tandem Mobi insulin pump with interoperable technology
K233044 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 10d
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
K220451 · DJG
Randox Laboratories Limited
Chemistry · 595d
Cleared Oct 03, 2023
endo.digital Platform
K232722 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 28d
Cleared Sep 29, 2023
Miris Human Milk Analyzer (HMA)
K223085 · QEI
Miris AB
Chemistry · 364d
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900 · CHL
Nova Biomedical Corporation
Chemistry · 456d
Cleared Sep 27, 2023
CEDIA Heroin Metabolite (6-AM) Assay
K231007 · DJG
Microgenics Corporation
Chemistry · 173d
Cleared Sep 27, 2023
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
K214117 · LCP
Abbott Diagnostics Technologies AS
Chemistry · 636d
Cleared Sep 26, 2023
EasyStat 300
K220396 · CEM
Medica Corporation
Chemistry · 592d
Cleared Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 601d
Cleared Sep 22, 2023
iLet® Dosing Decision Software
K232224 · QJI
Beta Bionics, Inc.
Chemistry · 57d
Cleared Sep 22, 2023
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · MRG
Immunostics Inc.,
Chemistry · 457d
Cleared Sep 20, 2023
Cholestech LDX ™ System
K223179 · CGA
Alere San Diego, Inc.
Chemistry · 344d
Cleared Sep 18, 2023
Access Myoglobin
K231832 · DDR
Beckman Coulter, Inc.
Chemistry · 88d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Sep 13, 2023
AlloMap Heart Molecular Expression Testing
K221640 · OJQ
Caredx, Inc.
Chemistry · 464d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · CGA
Abbott Point of Care, Inc.
Chemistry · 270d
Cleared Sep 08, 2023
ISE Electrodes
K230890 · CEM
Randox Laboratories, Ltd.
Chemistry · 161d
Cleared Sep 08, 2023
Minuteful-kidney test
K222921 · JIR
Healthy.Io, Ltd.
Chemistry · 347d
Cleared Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · CEW
Ortho-Clinical Diagnostics
Chemistry · 498d
Cleared Aug 24, 2023
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K220085 · OIF
Kronus, Inc.
Chemistry · 590d