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"
73–96 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Feb 13, 2026
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 266d
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