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

5,530 results for "blood"
97–120 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared May 02, 2025
Wrist Blood Pressure Monitor (AOJ-35A)
K250161 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 101d
Cleared May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · CHL
Abbott Point of Care, Inc.
Chemistry · 127d
Cleared Apr 30, 2025
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 35d
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 18, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay
K243013 · PEN
Luminex Corporation
Microbiology · 203d
Cleared Apr 14, 2025
Elfor-L
K243852 · DPW
Elfi-Tech , Ltd.
General & Plastic Surgery · 119d
Cleared Apr 08, 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 81d
Cleared Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
K242209 · PTC
Apex BioTechnology Corp.
Chemistry · 249d
Cleared Mar 28, 2025
PBC Separator with Selux AST System
K244044 · QZX
Selux Diagnostics, Inc.
Microbiology · 88d
Cleared Mar 21, 2025
BD Vacutainer® Multiple Sample Luer Adapter
K243649 · JKA
Becton, Dickinson and Company
General Hospital · 115d
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 27, 2025
PIVO™ Pro Needle-free Blood Collection Device
K241586 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 269d
Cleared Feb 26, 2025
Heel Incision Safety Lancet (SteriHeel 2)
K244036 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
Cleared Feb 26, 2025
Disposable Blood Lancet (Soft Pro)
K244031 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
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
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · NBW
Guangdong Transtek Medical...
Chemistry · 125d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d