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
169–192 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 05, 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · LCX
Assure Tech. (Hangzhou) Co, Ltd.
Chemistry · 130d
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 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 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