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"
49–72 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Feb 12, 2026
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
K252490 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 188d
Cleared Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744 · DTM
Medtronic
Cardiovascular · 224d
Cleared Jan 16, 2026
VITAL Tubing Sets for Hemodialysis
K251341 · FJK
Vital Healthcare Sdn. Bhd.
Gastroenterology & Urology · 261d
Cleared Jan 12, 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 259d
Cleared Jan 09, 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 29d
Cleared Jan 09, 2026
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
K253142 · DXN
Ningbo Ranor Medical Technology Co.,...
Cardiovascular · 106d
Cleared Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 194d
Cleared Dec 19, 2025
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
K251143 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 249d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Dec 09, 2025
Lancing device (HH-XV-T)
K253706 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 15d
Cleared Nov 20, 2025
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K251904 · DPW
Remington Medical, Inc.
Cardiovascular · 153d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Affinity Biosensors, LLC
Microbiology · 131d
Cleared Oct 27, 2025
Blood Pressure Monitor (B73, BE23T)
K251331 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 180d
Cleared Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · NBW
ACON Laboratories, Inc.
Chemistry · 270d
Cleared Oct 09, 2025
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
K251795 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 119d
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Oct 02, 2025
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125,...
K252769 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2025
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
K251442 · FJK
Ningbo Tianyi Medical Appliance Co.,...
Gastroenterology & Urology · 146d
Cleared Sep 25, 2025
Steripath® Flow™ Blood Collection System
K251812 · JKA
Magnolia Medical Technologies
General Hospital · 105d
Cleared Sep 03, 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · DXQ
Avita Corporation
Cardiovascular · 174d
Cleared Sep 03, 2025
Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X,...
K250231 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 219d
Cleared Aug 25, 2025
Quantra QStat Cartridge
K251404 · QFR
Hemosonics, LLC
Hematology · 111d
Cleared Aug 06, 2025
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP...
K251120 · DXN
Microlife Corporation
Cardiovascular · 117d
Cleared Aug 04, 2025
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors...
K251762 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 56d