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"
553–576 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 18, 2020
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · PEN
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Feb 28, 2020
Steripath Gen2 Blood Collection System
K192247 · JKA
Magnolia Medical Technologies, Inc.
General Hospital · 193d
Cleared Feb 21, 2020
Upper Arm Blood Pressure Monitor
K191894 · DXN
Shenzhen Zhengkang Technology Co., Ltd.
Cardiovascular · 221d
Cleared Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · NBW
Lifescan Europe GmbH
Chemistry · 60d
Cleared Feb 06, 2020
BreathID Smart System
K193610 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 42d
Cleared Feb 04, 2020
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button...
K191832 · JKA
Kurin, Inc.
General Hospital · 210d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW
I-Sens, Inc.
Chemistry · 112d
Cleared Jan 23, 2020
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
K192092 · DXN
Seca GmbH & Co. KG
Cardiovascular · 171d
Cleared Jan 21, 2020
PIVO(TM)
K193569 · JKA
Velano Vascular
General Hospital · 29d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · NBW
I-Sens, Inc.
Chemistry · 25d
Cleared Jan 10, 2020
FlowMet
K192966 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 79d
Cleared Jan 02, 2020
OC-Auto SENSOR io iFOB Test
K191147 · OOX
Eiken Chemical Co., Ltd.
Hematology · 247d
Cleared Dec 23, 2019
Arm Blood Pressure Monitor
K192023 · DXN
Truly Instrument Limited
Cardiovascular · 147d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW
I-Sens, Inc.
Chemistry · 120d
Cleared Dec 03, 2019
Promisemed Heel Blood Lancet
K193009 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 36d
Cleared Dec 02, 2019
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K192666 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 68d
Cleared Nov 27, 2019
Upper Arm Blood Pressure Monitor
K191673 · DXN
Famidoc Technology Company Limited
Cardiovascular · 156d
Cleared Nov 13, 2019
AMICUS Separator System
K192150 · LKN
Fresenius Kabi AG
Gastroenterology & Urology · 96d
Cleared Nov 08, 2019
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood...
K191286 · NBW
Ascensia Diabetes Care
Chemistry · 179d
Cleared Nov 05, 2019
TAP Blood Collection Device
K190225 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 273d
Cleared Nov 01, 2019
MDT2 BLE Self-Monitoring Blood Glucose System
K190189 · NBW
Eps Bio Technology Corp.
Chemistry · 273d
Cleared Oct 27, 2019
EarlyVue VS30
K190624 · DSJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 230d
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325 · LGZ
Life Warmer, Inc.
General Hospital · 52d