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"
289–312 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jul 28, 2023
Blood Tubing Lines for Hemodialysis AV06C-E
K231589 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 57d
Cleared Jul 26, 2023
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
K222994 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 301d
Cleared Jul 17, 2023
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum...
K213953 · JKA
Becton, Dickinson and Company
Chemistry · 577d
Cleared Jul 14, 2023
FlowSaver Blood Return System (80-101)
K231782 · CAC
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Jul 07, 2023
Blood Collection Set, Blood Collection Set with Holder, Safety Blood...
K230080 · JKA
Yangzhou Medline Industry, Co., Ltd.
General Hospital · 177d
Cleared Jun 30, 2023
Unistik® ShieldLock, Unistik VacuFlip
K223854 · JKA
Owen Mumford, Ltd.
General Hospital · 189d
Cleared Jun 30, 2023
Blood Pressure Monitor
K223374 · DXN
Guangdong Transtek Medical...
Cardiovascular · 238d
Cleared Jun 29, 2023
Upper Arm Blood Pressure Monitor
K230176 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 157d
Cleared Jun 28, 2023
Aneroid Sphygmomanometer
K230859 · DXQ
Wenzhou Kangshun Medical Devices Co.,Ltd
Cardiovascular · 91d
Cleared Jun 28, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
K230075 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 169d
Cleared Jun 28, 2023
MIO Blood Glucose Monitoring System
K223722 · NBW
Mio Labs, Inc.
Chemistry · 198d
Cleared Jun 27, 2023
Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort...
K231124 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 68d
Cleared Jun 21, 2023
PAXgene® Blood DNA Tube
K231469 · PJE
Preanalytix GmbH
Chemistry · 30d
Cleared Jun 21, 2023
Accurate 24 Non-invasive blood pressure monitor
K222658 · DXN
Accurate Meditech, Inc.
Cardiovascular · 292d
Cleared Jun 16, 2023
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines...
K230514 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 112d
Cleared Jun 14, 2023
Electronic Blood Pressure Monitor
K223291 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 231d
Cleared Jun 13, 2023
SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1...
K230759 · QRK
Bosungmeditech Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jun 10, 2023
BMR 1900 PHISIO
K223361 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 219d
Cleared Jun 05, 2023
Fluido Compact Blood and Fluid Warming System
K211618 · LGZ
The Surgical Company International B.V.
General Hospital · 740d
Cleared Jun 01, 2023
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
K230408 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 106d
Cleared May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
K213992 · FJK
Fresenius Medical Care Renal...
Gastroenterology & Urology · 526d
Cleared May 19, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
K222979 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 233d
Cleared May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors,...
K220842 · KFM
Qura S.R.L
Cardiovascular · 422d
Cleared May 05, 2023
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model...
K222926 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 221d