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

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5,555 results for "blood"
577–600 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 20, 2020
Bioland Blood Glucose Monitoring System
K191657 · NBW
Bioland Technology, Ltd.
Chemistry · 273d
Cleared Mar 18, 2020
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · PEN
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Feb 28, 2020
Steripath Gen2 Blood Collection System
K192247 · JKA
Magnolia Medical Technologies, Inc.
General Hospital · 193d
Cleared Feb 21, 2020
Upper Arm Blood Pressure Monitor
K191894 · DXN
Shenzhen Zhengkang Technology Co., Ltd.
Cardiovascular · 221d
Cleared CT Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · NBW
Lifescan Europe GmbH
Chemistry · 60d
Cleared Feb 06, 2020
BreathID Smart System
K193610 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 42d
Cleared Feb 04, 2020
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button...
K191832 · JKA
Kurin, Inc.
General Hospital · 210d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW
I-Sens, Inc.
Chemistry · 112d
Cleared Jan 23, 2020
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
K192092 · DXN
Seca GmbH & Co. KG
Cardiovascular · 171d
Cleared Jan 21, 2020
PIVO(TM)
K193569 · JKA
Velano Vascular
General Hospital · 29d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · NBW
I-Sens, Inc.
Chemistry · 25d
Cleared Jan 10, 2020
FlowMet
K192966 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 79d
Cleared Jan 02, 2020
OC-Auto SENSOR io iFOB Test
K191147 · OOX
Eiken Chemical Co., Ltd.
Hematology · 247d
Cleared Dec 23, 2019
Arm Blood Pressure Monitor
K192023 · DXN
Truly Instrument Limited
Cardiovascular · 147d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW
I-Sens, Inc.
Chemistry · 120d
Cleared Dec 03, 2019
Promisemed Heel Blood Lancet
K193009 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 36d
Cleared Dec 02, 2019
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K192666 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 68d
Cleared Nov 27, 2019
Upper Arm Blood Pressure Monitor
K191673 · DXN
Famidoc Technology Company Limited
Cardiovascular · 156d
Cleared Nov 13, 2019
AMICUS Separator System
K192150 · LKN
Fresenius Kabi AG
Gastroenterology & Urology · 96d
Cleared Nov 08, 2019
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood...
K191286 · NBW
Ascensia Diabetes Care
Chemistry · 179d
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 27, 2019
EarlyVue VS30
K190624 · DSJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 230d