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
457–480 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 05, 2019
TAP Blood Collection Device
K190225 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 273d
Cleared Nov 01, 2019
MDT2 BLE Self-Monitoring Blood Glucose System
K190189 · NBW
Eps Bio Technology Corp.
Chemistry · 273d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · LCP
Ixensor Co, Ltd.
Chemistry · 60d
Cleared Oct 25, 2019
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
K192787 · QDK
Dexcom, Inc.
Chemistry · 25d
Cleared Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
K192175 · NBW
ACON Laboratories, Inc.
Chemistry · 66d
Cleared Oct 07, 2019
Dexcom G6 Pro Continuous Glucose Monitoring System
K191833 · QII
Dexcom, Inc.
Chemistry · 90d
Cleared Oct 04, 2019
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate,...
K190298 · CDD
Beckman Coulter Biomedical GmbH
Chemistry · 235d
Cleared Oct 03, 2019
Yumizen C1200 CRP
K191993 · DCK
HORIBA ABX SAS
Chemistry · 70d
Cleared Oct 02, 2019
LIAISON Vitamin B12
K192064 · CDD
DiaSorin, Inc.
Chemistry · 62d
Cleared Sep 20, 2019
Omnipod DASH Insulin Management System with interoperable technology
K191679 · QFG
Insulet Corporation
Chemistry · 88d
Cleared CT Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 88d
Cleared Sep 05, 2019
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip,...
K192123 · LCX
Qingdao Hightop Biotech Co., Ltd.
Chemistry · 30d
Cleared Aug 30, 2019
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · CJE
HORIBA ABX SAS
Chemistry · 113d
Cleared Aug 30, 2019
Lumipulse G whole PTH
K190702 · CEW
Fujirebio Diagnostics,Inc.
Chemistry · 165d
Cleared Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 79d
Cleared Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro...
K191899 · CFR
Roche Diagnostics
Chemistry · 31d
Cleared Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · JFP
Nova Biomedical Corporation
Chemistry · 59d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230 · LCP
Drawbridge Health, Inc.
Chemistry · 268d
Cleared Aug 01, 2019
MAGLUMI 2000 25-OH Vitamin D
K191499 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 56d
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454 · JFJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 29, 2019
Quantisal II Oral Fluid Collection Device
K183048 · PJD
Immunalysis Corporation
Chemistry · 269d
Cleared Jul 26, 2019
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396 · CJY
HORIBA ABX SAS
Chemistry · 63d
Cleared Jul 26, 2019
ACR LAB Urine Analysis Test System
K182384 · JFY
Healthy.Io, Ltd.
Chemistry · 329d