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"
169–192 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Oct 24, 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
K241007 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 195d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324 · SAN
Affinity Biosensors, LLC
Microbiology · 166d
Cleared Oct 22, 2024
Arm Type Blood Pressure Monitor (BPM82)
K242193 · DXN
Avita Corporation
Cardiovascular · 88d
Cleared Oct 16, 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205,...
K241613 · DXN
Shenzhen Hbcare Technology Co.,Ltd
Cardiovascular · 133d
Cleared Oct 08, 2024
Sejoy Blood Glucose Monitoring System
K240640 · NBW
Sejoy Biomedical Co., Ltd.
Chemistry · 216d
Not Cleared Oct 08, 2024
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection...
DEN230076 · QXY
Omron Healthcare, Inc.
Cardiovascular · 330d
Cleared Oct 04, 2024
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113,...
K242721 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 24d
Cleared Sep 26, 2024
Accelerate Arc System
K240854 · QNJ
Accelerate Diagnostics, Inc.
Microbiology · 182d
Cleared Sep 12, 2024
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood...
K231982 · DTZ
Qura S.R.L
Cardiovascular · 435d
Cleared Aug 30, 2024
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K241583 · DPW
Remington Medical, Inc.
Cardiovascular · 88d
Cleared Aug 28, 2024
Safety Lancet
K242316 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 23d
Cleared Aug 27, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K241787 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 67d
Cleared Aug 21, 2024
Blood Pressure Monitor (TMB-2092-G)
K241351 · DXN
Guangdong Transtek Medical...
Cardiovascular · 100d
Cleared Aug 20, 2024
MedtFine Safety Lancet
K241848 · FMK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 54d
Cleared Aug 16, 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood...
K222126 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 760d
Cleared Aug 15, 2024
MICROLET®NEXT Lancet
K241810 · QRK
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 55d
Cleared Aug 15, 2024
Medifun Safety Lancet ( MSL1 series)
K241750 · FMK
Medifun Corporation
General & Plastic Surgery · 58d
Cleared Jul 26, 2024
Cell-Free DNA BCT
K231776 · QMA
Streck, Inc.
Chemistry · 406d
Cleared Jul 19, 2024
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · JKA
Greiner Bio-One North America, Inc.
General Hospital · 214d
Cleared Jul 18, 2024
Quantum Perfusion Hybrid System
K241206 · DTN
Spectrum Medical S.R.L.
Cardiovascular · 79d
Cleared Jul 03, 2024
Upper Arm Electronic Blood Pressure Monitor
K241129 · DXN
Shenzhen Goodlymed Technology Co., Ltd.
Cardiovascular · 70d
Cleared Jun 20, 2024
Safety Lancet (XXXV)
K241627 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 14d
Cleared Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K230675 · SAN
Specific Diagnostics, LLC
Microbiology · 468d
Cleared Jun 14, 2024
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39,...
K240729 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 88d