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"
361–384 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Nov 28, 2022
Aneroid Sphygmomanometer
K222652 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 88d
Cleared Nov 23, 2022
LDE4 Lancing Device
K222656 · QRL
I-Sens, Inc.
General & Plastic Surgery · 82d
Cleared Nov 22, 2022
GUS610 Blood pressure monitor
K222160 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 125d
Cleared Nov 21, 2022
Disposable Blood Pressure Cuff
K222420 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 102d
Cleared Nov 21, 2022
Disposable Sterile Lancet
K222246 · QRL
Tianjin Rilifine Medical Device Co.,...
General & Plastic Surgery · 118d
Cleared Nov 18, 2022
CONTOUR® NEXT GEN Blood Glucose Monitoring System
K223293 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 23d
Cleared Nov 18, 2022
Facet Blood Lancets
K222539 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 88d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Nov 15, 2022
Disposable Sterile Lancet
K222055 · FMK
Tianjin Rilifine Medical Device Co.,...
General & Plastic Surgery · 126d
Cleared Nov 15, 2022
LifeSPARC System
K211830 · QNR
Cardiacassist, Inc.
Cardiovascular · 519d
Cleared Nov 10, 2022
BreathID® Smart System
K223185 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 29d
Cleared Nov 10, 2022
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K222067 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 120d
Cleared Nov 07, 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
K221833 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 137d
Cleared Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring...
K220421 · NBW
Apex BioTechnology Corp.
Chemistry · 263d
Cleared Nov 03, 2022
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie...
K222168 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 105d
Cleared Nov 02, 2022
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance...
K222084 · FMK
Asahi Polyslider Co., Ltd.
General & Plastic Surgery · 110d
Cleared Oct 28, 2022
Disposable Safety Lancet
K221521 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 156d
Cleared Oct 26, 2022
Eclipse Blood Collection Set
K213690 · JKA
Eclipse Medcorp, LLC
General Hospital · 337d
Cleared Oct 25, 2022
Unistik® Pro
K222303 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 85d
Cleared Oct 24, 2022
SafetiCET Safety Lancet
K221783 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 125d
Cleared Oct 21, 2022
Safety Blood Collection Needle (Without Needle Holder)
K222141 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 93d
Cleared Oct 18, 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · QRL
Trividia Health
General & Plastic Surgery · 189d
Cleared Oct 17, 2022
YUWELL Electronic Blood Pressure Monitor
K221372 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 158d
Cleared Oct 17, 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
K221175 · QRL
Arkray, Inc.
General & Plastic Surgery · 175d