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"
481–504 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 08, 2021
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
K211127 · DXN
Health & Life Co., Ltd.
Cardiovascular · 145d
Cleared Sep 06, 2021
SANSIN Tubing Sets for Hemodialysis
K202796 · FJK
Jiangxi Sanxin Medtec Co., Ltd.
Gastroenterology & Urology · 348d
Cleared Sep 01, 2021
EASYMAX Tag Self-Monitoring Blood Glucose System
K201258 · NBW
Eps Bio Technology Corp.
Chemistry · 478d
Cleared Aug 30, 2021
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor,...
K211041 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 144d
Cleared Aug 26, 2021
Heel Incision Safety Lancet
K210745 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 167d
Cleared Aug 20, 2021
GEM Premier 5000
K203790 · CHL
Instrumentation Laboratory CO
Chemistry · 235d
Cleared Aug 13, 2021
Caretaker Platform, VitalStream Platform, CT5
K211588 · DXN
Caretaker Medical
Cardiovascular · 81d
Cleared Aug 13, 2021
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103,...
K210671 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 161d
Cleared Aug 12, 2021
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
K210661 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 161d
Cleared Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
K210687 · NBW
Ascensia Diabetes Care
Chemistry · 156d
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986 · CHL
Opti Medical Systems, Inc.
Chemistry · 474d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 137d
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 136d
Cleared Jul 22, 2021
FlowSaver Blood Filter
K210176 · CAC
Inari Medical
Cardiovascular · 181d
Cleared Jul 21, 2021
CHIRAVAC Blood Collection Needles
K201009 · JKA
Chirana T. Injecta
General Hospital · 460d
Cleared Jul 13, 2021
Finetest Lite Blood Glucose Monitoring System
K203562 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 218d
Cleared Jun 25, 2021
Safety Winged Blood Collection Sets
K211293 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 60d
Cleared Jun 10, 2021
Blood Administration Set
K210335 · BRZ
Baxter Healthcare Corporation
General Hospital · 125d
Cleared Jun 07, 2021
HRVWatch-Mini Wrist Monitor
K201914 · DXN
Taiwan Scientific Corporation
Cardiovascular · 333d
Cleared May 12, 2021
Automatic Arm Electronic Blood Pressure Monitor
K210435 · DXN
Shenzhen Lepu Intelligent Medical...
Cardiovascular · 89d
Cleared Apr 28, 2021
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer,...
K202757 · DXN
Contec Medical Systems Co.,Ltd
Cardiovascular · 219d
Cleared Apr 09, 2021
EasyPoint Blood Collection Plus
K202325 · JKA
Retractable Technologies, Inc.
General Hospital · 235d
Cleared Apr 08, 2021
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K202729 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 202d