FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
289–312 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 07, 2022
SuperCheck Pro Blood Glucose Monitoring System
K213061 · NBW
Ok Biotech Co., Ltd.
Chemistry · 380d
Cleared Sep 21, 2022
Clearblue ® Early Pregnancy Test
K213379 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 343d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d
Cleared Aug 29, 2022
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW
Hmd Biomedical, Inc.
Chemistry · 406d
Cleared Aug 25, 2022
GlucoSure Link Blood Glucose Monitoring System
K212140 · NBW
Apex BioTechnology Corp.
Chemistry · 413d
Cleared Aug 19, 2022
SmartBolus Calculator
K222239 · QRX
Insulet Corporation
Chemistry · 24d
Cleared Aug 19, 2022
SmartAdjust(TM) technology
K220394 · QJI
Insulet Corporation
Chemistry · 189d
Cleared Aug 12, 2022
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood...
K202739 · NBW
Bioland Technology, Ltd.
Chemistry · 693d
Cleared Jul 29, 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose...
K221259 · QBJ
Dexcom, Inc.
Chemistry · 88d
Cleared Jul 08, 2022
VIDAS NEPHROCHECK
K210793 · PIG
Biom?rieux SA
Chemistry · 479d
Cleared Jul 06, 2022
Minuteful - kidney test
K210069 · JIR
Healthy.Io, Ltd.
Chemistry · 541d
Cleared Jun 30, 2022
hCG One Step Pregnancy Test
K212418 · LCX
Healstone Biotech, Inc.
Chemistry · 331d
Cleared Jun 30, 2022
Cholesterol2
K203597 · CHH
Abbott Ireland Diagnostics Division
Chemistry · 568d
Cleared Jun 16, 2022
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
K201037 · NBW
Taidoc Technology Corporation
Chemistry · 787d
Cleared Jun 10, 2022
Elecsys AMH
K203757 · PQO
Roche Diagnostics
Chemistry · 534d
Cleared May 31, 2022
Urea Nitrogen2
K203771 · CDQ
Abbott Ireland Diagnostics Division
Chemistry · 524d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K212132 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 322d
Cleared May 26, 2022
Amylase2
K210633 · JFJ
Abbott Ireland Diagnostics Division
Chemistry · 449d
Cleared May 23, 2022
Assure Titanium Blood Glucose Monitoring System
K200788 · PZI
Arkray, Inc.
Chemistry · 788d
Cleared May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
K202525 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 625d
Cleared May 06, 2022
Elecsys Testosterone II
K211685 · CDZ
Roche Diagnostics
Chemistry · 338d
Cleared May 06, 2022
IWL2020 Blood Glucose Monitoring System
K203711 · NBW
Roche Diabetes Care, Inc.
Chemistry · 501d
Cleared Apr 06, 2022
Extended Reservoir
K210714 · LZG
Medtronic Minimed, Inc.
Chemistry · 392d