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
193–216 of 13,234
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
K230285 · CHL
Abbott Point of Care, Inc.
Chemistry · 267d
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