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
241–264 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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
Cleared Jun 21, 2023
PAXgene® Blood DNA Tube
K231469 · PJE
Preanalytix GmbH
Chemistry · 30d