FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
2,375 results for "blood"
49–72 of 2,375
Search insights Median review: 92d Cleared: 100% Top manufacturer: Andon Health Co, Ltd. Lead specialty: Cardiovascular
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 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 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared May 02, 2025
Wrist Blood Pressure Monitor (AOJ-35A)
K250161 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 101d
Cleared Apr 30, 2025
Arm Blood Pressure Monitor (ARM-30A+)
K244000 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 125d
Cleared Apr 24, 2025
Arm Blood Pressure Monitor (ARM-30H)
K250116 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 98d
Cleared Apr 08, 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 81d
Cleared Mar 21, 2025
FloTrac sensors
K242909 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 178d
Cleared Mar 14, 2025
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · DXN
Korot Co., Ltd.
Cardiovascular · 59d
Cleared Feb 21, 2025
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including...
K243115 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 144d
Cleared Feb 19, 2025
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323,...
K241578 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 261d
Cleared Feb 11, 2025
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
K241634 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 250d
Cleared Feb 07, 2025
Electronic Blood Pressure Monitor
K243661 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 72d
Cleared Feb 05, 2025
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
K242352 · DXN
Accurate Meditech, Inc.
Cardiovascular · 181d
Cleared Feb 03, 2025
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08,...
K241590 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 245d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d
Cleared Jan 23, 2025
Vios Monitoring System(TM) Model 2050
K241728 · DXN
Murata Vios, Inc.
Cardiovascular · 223d
Cleared Jan 14, 2025
BB-613-BPM
K241066 · DXN
Biobeat Technologies , Ltd.
Cardiovascular · 271d
Cleared Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
K241431 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 237d
Cleared Jan 10, 2025
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269,...
K242528 · DXN
Shenzhen Ruiankang Technology Co., Ltd.
Cardiovascular · 137d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Nov 26, 2024
Arm Blood Pressure Monitor (model: BPM-A7VL)
K243118 · DXN
Shenzhen Imdk Medical Technology Co.,...
Cardiovascular · 57d
Cleared Nov 18, 2024
MICRO Arterial Filters
K242092 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 124d