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"
145–168 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
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
Cleared Jun 07, 2024
Blood Pressure Monitor (BBZ32-AA01)
K240832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 73d