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

Filters:
5,555 results for "blood"
217–240 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Feb 15, 2024
PBC Separator with Selux AST System
K223493 · QZX
Selux Diagnostics, Inc.
Microbiology · 451d
Cleared Feb 08, 2024
T2Bacteria® Panel
K233184 · QBX
T2biosystems, Inc.
Microbiology · 133d
Cleared Feb 08, 2024
eQUANT System
K231536 · QZX
Avails Medical, Inc.
Microbiology · 254d
Cleared Feb 02, 2024
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Jan 26, 2024
CentriMag™ Acute Circulatory Support System
K234118 · QNR
Abbott Medical
Cardiovascular · 29d
Cleared Jan 26, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor
K231303 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 266d
Cleared Jan 26, 2024
LifeOutcomes C-Quest™ Blood Culture Sampling Device
K231282 · JKA
Lifeoutcomes, LLC
General Hospital · 268d
Cleared Jan 25, 2024
Facet Aurora Reusable Lancet Base
K232912 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 128d
Cleared Jan 19, 2024
LifeSPARC System
K233736 · QNR
Cardiacassist, Inc.
Cardiovascular · 58d
Cleared Jan 19, 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · NBW
Bionime Corporation
Chemistry · 267d
Cleared Jan 16, 2024
Disposable safety lancet (Impress)
K233796 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 48d
Cleared Jan 11, 2024
SurgiCount+ System
K232250 · PBZ
Stryker Instruments
General & Plastic Surgery · 167d
Cleared Jan 04, 2024
Lancing System
K232330 · QRK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 154d
Cleared Jan 04, 2024
Pursuant Health Kiosk (G1.D5)
K230996 · DXN
Pursuant Health
Cardiovascular · 272d
Cleared Dec 22, 2023
VivaChek Link Plus Blood Glucose Monitoring System
K233058 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 88d
Cleared Dec 22, 2023
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood...
K232881 · JKA
Jiangsu Kangbao Medical Equipment...
General Hospital · 95d
Cleared Dec 21, 2023
Reusable Blood Pressure Cuff
K233276 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 83d
Cleared Dec 20, 2023
Blood Pressure Monitor
K233130 · DXN
Guangdong Transtek Medical...
Cardiovascular · 84d
Cleared Dec 20, 2023
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · JKA
Becton, Dickinson and Company
Chemistry · 267d
Cleared Dec 15, 2023
Digital Blood Pressure Monitor (Model: YB-800)
K231478 · DXN
Wenzhou Yosun Medical Technology Co.,Ltd
Cardiovascular · 207d
Cleared Dec 11, 2023
Wrist Blood Pressure Monitor
K232815 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 89d
Cleared Dec 08, 2023
SimpleSense-BP, SimpleSense-BP Software Application
K232053 · DXN
Nanowear, Inc.
Cardiovascular · 150d
Cleared Dec 06, 2023
SG Lanset I, SG Lancets, Soft Lancets
K230712 · QRK
Sewon Medical Co.
General & Plastic Surgery · 266d