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
313–336 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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
Cleared Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · NBW
Apex BioTechnology Corp.
Chemistry · 582d
Cleared Apr 05, 2022
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip,...
K213808 · LCX
Co-Innovation Biotech Co., Ltd.
Chemistry · 120d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · NBC
Roche Diagnostics
Chemistry · 399d
Cleared Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · NBW
Apex BioTechnology Corp.
Chemistry · 106d