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"
265–288 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Sep 29, 2023
Boppli Infant Blood Pressure Monitor
K223873 · DXN
Pyrames, Inc.
Cardiovascular · 280d
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900 · CHL
Nova Biomedical Corporation
Chemistry · 456d
Cleared Sep 29, 2023
AnemoCheck Home
K221508 · KHG
Sanguina, Inc.
Hematology · 493d
Cleared Sep 29, 2023
UltraFlo-R Push Button Blood Collection Set
K220458 · JKA
Innovative Medical Technologies, Inc.
General Hospital · 589d
Cleared Sep 28, 2023
PIVO™ Pro Needle-free Blood Collection Device
K230865 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 183d
Cleared Sep 18, 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201,...
K231367 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 130d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Sep 15, 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource...
K223788 · FOZ
Medsource International, LLC
General Hospital · 270d
Cleared Sep 08, 2023
STAT Medical Device Lancing System
K230310 · QRK
Stat Medical Devices
General & Plastic Surgery · 217d
Cleared Sep 07, 2023
Digital Blood Pressure Monitor WBP Series
K231542 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 100d
Cleared Sep 07, 2023
Arm Blood Pressure Monitor
K230649 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 182d
Cleared Aug 30, 2023
NIBPCuff
K231961 · DXQ
Shenzhen Sino-K Medical Technology...
Cardiovascular · 58d
Cleared Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K230566 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 177d
Cleared Aug 25, 2023
Wrist Type Blood Pressure Monitor (W05,W1101L)
K230409 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 191d
Cleared Aug 25, 2023
VitalFlow™ Console
K230364 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 196d
Cleared Aug 25, 2023
VitalFlowTM Centrifugal Pump
K223898 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 240d
Cleared Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood...
K213670 · GIM
Becton, Dickinson and Company
Hematology · 641d
Cleared Aug 24, 2023
Quantra Hemostasis Analyzer
K232215 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Aug 11, 2023
Electronic Blood Pressure Monitor
K230642 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 156d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW
I-Sens, Inc.
Chemistry · 157d
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608 · CHL
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Aug 10, 2023
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
K213131 · NBW
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 03, 2023
LifeSPARC System
K232132 · KFM
Cardiacassist, Inc.
Cardiovascular · 16d
Cleared Aug 02, 2023
BPBIO750
K231174 · DXN
Inbody Co., Ltd.
Cardiovascular · 99d