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
217–240 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 24, 2023
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K220085 · OIF
Kronus, Inc.
Chemistry · 590d
Cleared Aug 23, 2023
Access Folate Assay
K223590 · CGN
Beckman Coulter, Inc.
Chemistry · 265d
Cleared Aug 18, 2023
IDS ACTH II
K223867 · CKG
Immunodiagnostic Systems Limited
Chemistry · 238d
Cleared Aug 11, 2023
BlueStar CGM insulin dose calculator
K222888 · QRX
Welldoc, Inc.
Chemistry · 322d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW
I-Sens, Inc.
Chemistry · 157d
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608 · CHL
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Aug 10, 2023
Accu-Chek Solo micropump system with interoperable technology
K213134 · QFG
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 10, 2023
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
K213131 · NBW
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Jul 28, 2023
BlueStar and BlueStar Rx
K230813 · NDC
Welldoc, Inc.
Chemistry · 126d
Cleared Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
K223781 · PJD
Immunalysis Corporation
Chemistry · 224d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · CGA
Abbott Point of Care, Inc.
Chemistry · 228d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 347d
Cleared Jul 25, 2023
DEKA ACE Pump System
K213536 · QFG
Deka Research and Development
Chemistry · 627d
Cleared Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · NBC
Roche Diagnostics
Chemistry · 228d
Cleared Jul 21, 2023
Alkaline Phosphatase2
K223317 · CJE
Abbott Ireland Diagnostics Division
Chemistry · 266d
Cleared Jul 20, 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
K220977 · JGS
Beckman Coulter Laboratory Systems...
Chemistry · 472d
Cleared Jul 19, 2023
AXINON® LDL-p Test System
K210801 · MRR
Numares AG
Chemistry · 854d
Cleared Jul 17, 2023
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum...
K213953 · JKA
Becton, Dickinson and Company
Chemistry · 577d
Cleared Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra...
K222116 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 360d
Cleared Jul 10, 2023
Tandem Mobi Insulin Pump with Interoperable Technology
K223213 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 266d
Not Cleared Jul 07, 2023
BT-001
DEN220058 · QXC
Better Therapeutics
Chemistry · 289d
Not Cleared Jun 29, 2023
KidneyIntelX.dkd
DEN200052 · QWZ
Renalytix Ai, Inc.
Chemistry · 1037d
Cleared Jun 28, 2023
MIO Blood Glucose Monitoring System
K223722 · NBW
Mio Labs, Inc.
Chemistry · 198d
Cleared Jun 21, 2023
iLet® ACE Pump
K231485 · QFG
Beta Bionics, Inc.
Chemistry · 29d