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"
97–120 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Aug 04, 2025
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors...
K251762 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 56d
Cleared CT Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
K251113 · DXN
Andon Health Co, Ltd.
Cardiovascular · 115d
Cleared Aug 04, 2025
Blood Volume Analyzer (200)
K251087 · JWO
Daxor Corporation
Hematology · 117d
Cleared Jul 30, 2025
ArteVu
K244007 · DXN
Cardio Ring Technologies, Inc. Taiwan...
Cardiovascular · 216d
Cleared Jul 16, 2025
Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L,...
K251102 · DXN
Cemho Medical Technology (Guangdong)...
Cardiovascular · 96d
Cleared Jul 15, 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 103d
Cleared Jul 14, 2025
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19,...
K250185 · DXN
Jiangxi Aicare Medical Technology...
Cardiovascular · 173d
Cleared Jul 03, 2025
BD Vacutainer® Eclipse™ Blood Collection Needle
K243207 · JKA
Becton, Dickinson and Company
General Hospital · 275d
Cleared CT Jul 02, 2025
G0 Blood Pressure Monitoring System (G0)
K250415 · DXN
Aktiia SA
Cardiovascular · 139d
Cleared Jul 01, 2025
droplet® personal lancets
K250016 · QRK
Htl-Strefa S.A
General & Plastic Surgery · 179d
Cleared Jun 27, 2025
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · JOY
Scopio Labs , Ltd.
Hematology · 270d
Cleared Jun 26, 2025
safety lancet
K251694 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 24d
Cleared Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 121d
Cleared Jun 24, 2025
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors...
K250326 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 139d
Cleared Jun 20, 2025
FloPatch FP120
K251114 · DPW
Flosonics Medical
Cardiovascular · 70d
Cleared Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490 · PAM
Luminex Corporation
Microbiology · 206d
Cleared Jun 04, 2025
Blood collection tube holders
K250961 · JKA
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 65d
Cleared Jun 02, 2025
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
K250965 · JPA
Sysmex America, Inc.
Hematology · 63d
Cleared May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150 · DTR
Sorin Group Italia S.R.L.
Cardiovascular · 129d
Cleared May 23, 2025
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · JKA
Venocare, Inc.
General Hospital · 143d
Cleared May 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared May 16, 2025
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
K242706 · SET
Fujirebio Diagnostics,Inc.
Immunology · 249d
Cleared May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
K242479 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 267d
Cleared May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
K242176 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 295d