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

5,555 results for "blood"
121–144 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared May 14, 2025
MICROLET®NEXT 2 Lancing Device
K250813 · QRL
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 58d
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