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
193–216 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 02, 2024
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Jan 31, 2024
Clearblue® Early Detection Pregnancy Test
K240025 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 28d
Cleared Jan 26, 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
K232864 · LCX
Nantong Egens Biotechnology Co., Ltd.
Chemistry · 133d
Cleared Jan 19, 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · NBW
Bionime Corporation
Chemistry · 267d
Cleared Jan 18, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · OPP
Cequr SA
Chemistry · 91d
Cleared Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 112d
Cleared Dec 22, 2023
VivaChek Link Plus Blood Glucose Monitoring System
K233058 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 88d
Cleared Dec 20, 2023
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · JKA
Becton, Dickinson and Company
Chemistry · 267d
Cleared Dec 20, 2023
Inessa System
K230545 · QFG
Triple Jump Israel , Ltd.
Chemistry · 295d
Cleared Dec 18, 2023
Access hsTnI
K222881 · MMI
Beckman Coulter, Inc.
Chemistry · 452d
Cleared Dec 12, 2023
Insulia Bolus Companion
K232451 · NDC
Voluntis Sa.
Chemistry · 120d
Cleared Dec 11, 2023
iFlash-HCG
K223690 · DHA
Shenzhen Yhlo Biotech Co., Ltd.
Chemistry · 367d
Cleared Dec 07, 2023
ProNephro AKI™ (NGAL)
K232761 · PIG
Bioporto Diagnostic, Inc.
Chemistry · 90d
Cleared CT Dec 06, 2023
Q-Pad Test System
K231465 · LCP
Qurasense
Chemistry · 201d
Cleared Dec 04, 2023
Access hsTnI
K230648 · MMI
Beckman Coulter, Inc.
Chemistry · 270d
Cleared Dec 01, 2023
TRUENESS™ AIR Blood Glucose Monitoring System
K231476 · NBW
Sinocare, Inc.
Chemistry · 193d
Cleared Dec 01, 2023
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™...
K230391 · JKA
Becton, Dickinson and Company
Chemistry · 290d
Cleared Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
K232898 · PJD
Immunalysis Corporation
Chemistry · 64d
Cleared Nov 09, 2023
ARK Hydrocodone Assay
K231752 · DJG
ARK Diagnostics, Inc.
Chemistry · 147d
Cleared CT Nov 03, 2023
Control-IQ Technology
K232382 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 87d
Cleared Nov 03, 2023
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 87d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · JFP
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL
Abbott Point of Care, Inc.
Chemistry · 267d