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"
649–672 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 21, 2019
A&D Medical Blood Pressure Monitors
K173191 · DXN
A&D Company, Ltd.
Cardiovascular · 535d
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 12, 2019
Microlife Digital Blood Pressure Monitor
K183469 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 88d
Not Cleared Mar 12, 2019
Quantra Hemostasis Analyzer, QPlus Cartridge
DEN180017 · QFR
Hemosonics, LLC
Hematology · 344d
Cleared Mar 03, 2019
Electronic Blood Pressure Monitor
K182495 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 173d
Cleared Mar 01, 2019
BD Vacutainer Eclipse UltraFill Blood Collection Needle
K181730 · FMI
Becton, Dickinson and Company
General Hospital · 245d
Cleared Feb 27, 2019
FlowMet-R
K182494 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 169d
Cleared Feb 14, 2019
GMC Wrist Automatic Blood Pressure Monitor
K181930 · DXN
Gmc, Inc.
Cardiovascular · 211d
Cleared Feb 13, 2019
U&U Blood Collection Sets
K181508 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 251d
Cleared Feb 12, 2019
FORA P100 Blood Pressure Monitoring System
K182934 · DXN
Taidoc Technology Corporation
Cardiovascular · 113d
Cleared Feb 11, 2019
BacT/ALERT FA Plus
K183166 · MDB
bioMerieux, Inc.
Microbiology · 88d
Cleared Feb 05, 2019
Spectra Optia Apheresis System
K183081 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Jan 28, 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775 · LGZ
Life Warmer, Inc.
General Hospital · 209d
Cleared Jan 25, 2019
MiniCollect K2E K2EDTA Tubes
K182078 · JKA
Greiner Bio-One Na, Inc.
Hematology · 176d
Cleared Jan 18, 2019
Kurin PIV Blood Collection Set with High Pressure
K181895 · JKA
Kurin, Inc.
General Hospital · 186d
Cleared Jan 03, 2019
Arm Blood Pressure Monitor
K180435 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 317d
Cleared Jan 02, 2019
Raycell MK1
K181737 · MOT
Best Theratronics Limited
Radiology · 184d
Cleared Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K182690 · PEO
Genmark Diagnostics, Incorporated
Microbiology · 85d
Cleared Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663 · PAM
Genmark Diagnostics, Incorporated
Microbiology · 178d
Cleared Dec 19, 2018
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...
K173140 · NBW
Vivachek Laboratories, Inc.
Chemistry · 446d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593 · JIN
Apex BioTechnology Corp.
Chemistry · 89d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · DXQ
Shenzhen Caremed Medical Technology...
Cardiovascular · 102d
Cleared Dec 14, 2018
iCertainty
K181269 · DPW
Rfpi
General & Plastic Surgery · 214d