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"
1–24 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Oct 30, 2026
Safe AQ Easy Blood Glucose Monitoring System
K260738 · NBW
Changsha Sinocare, Inc.
Chemistry · 238d
Cleared Oct 28, 2026
Profoject™ Safe Push Button Blood Collection Sets
K262242 · JKA
CMT Health PTE., Ltd.
General Hospital · 119d
Cleared Oct 28, 2026
YUWELL® Electronic Blood Pressure Monitor
K260670 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 240d
Cleared Oct 27, 2026
FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
K261714 · DPW
Transonic Systems, Inc.
Cardiovascular · 154d
Cleared Oct 23, 2026
EASYMAX Voice Blood Glucose Monitoring System
K261293 · NBW
Eps Bio Technology Corp.
Chemistry · 186d
Cleared Oct 22, 2026
Gravity Blood Sets with 200µm Filter
K260261 · FPA
B.Braun Medical, Inc.
General Hospital · 267d
Cleared Oct 21, 2026
Sol-Guard™ Safety Pull Button Collection Set
K260857 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 219d
Cleared Oct 16, 2026
BD Vacutainer® Serum Blood Collection Tubes
K252344 · JKA
Becton, Dickinson and Company
Chemistry · 445d
Cleared Oct 09, 2026
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System
K260687 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 220d
Cleared Oct 02, 2026
CVS Advanced PLUS Blood Glucose Monitoring System
K260689 · NBW
I-Sens, Inc.
Chemistry · 213d
Cleared Oct 02, 2026
Ninenovo Blood Oxygen Ring...
K260490 · DQA
Shenzhen Ninenovo Technology Limited
Anesthesiology · 231d
Cleared Oct 01, 2026
Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C,...
K260470 · DXN
Shenzhen Brav Electronic Technologies...
Cardiovascular · 231d
Cleared Sep 25, 2026
Profoject™ Safety Sliding Blood Collection Set
K262215 · JKA
CMT Health PTE., Ltd.
General Hospital · 87d
Cleared Sep 13, 2026
Safety lancet (XL)
K262526 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 53d
Cleared Sep 10, 2026
Upper Arm Blood pressure monitor (BP7155D)
K261929 · DXN
Omron Healthcare, Inc.
Cardiovascular · 93d
Cleared Sep 10, 2026
TruPress
K254074 · DRS
Procerus Enterprises
Cardiovascular · 266d
Cleared Sep 03, 2026
Happy Health Blood Pressure Monitor
K254000 · DXN
Happy Health, Inc.
Cardiovascular · 262d
Cleared Aug 27, 2026
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K260545 · NBW
Ascensia Diabetes Care
Chemistry · 190d
Cleared Aug 26, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus,...
K261394 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 119d
Cleared Aug 25, 2026
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
K262631 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 27d
Cleared Aug 19, 2026
Elecsys Phospho-Tau (217P) Plasma
K261686 · SET
Roche Diagnostics
Immunology · 90d
Cleared Aug 19, 2026
PrecivityAD2 Test
K253240 · SET
C2N Diagnostics, LLC
Immunology · 324d
Cleared Aug 18, 2026
Lancing device
K262135 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Aug 13, 2026
BP Go (BPP-855)
K261061 · DXN
Wellvii, Inc.
Cardiovascular · 135d