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"
409–432 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Aug 29, 2022
Blood Pressure Monitor
K220676 · DXN
Guangdong Transtek Medical...
Cardiovascular · 174d
Cleared Aug 29, 2022
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW
Hmd Biomedical, Inc.
Chemistry · 406d
Cleared Aug 26, 2022
Upper Arm Blood Pressure Monitor
K221212 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 121d
Cleared Aug 25, 2022
GlucoSure Link Blood Glucose Monitoring System
K212140 · NBW
Apex BioTechnology Corp.
Chemistry · 413d
Cleared Aug 23, 2022
OneTouch Delica Plus Lancing System
K221546 · QRL
Asahi Polyslider Co., Ltd.
General & Plastic Surgery · 88d
Cleared Aug 22, 2022
SafetiHeel, MediHeel, Novaplus
K221604 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 81d
Cleared Aug 17, 2022
Disposable Blood Lancets
K220387 · QRL
Suzhou Kyuan Medical Apparatus Co., Ltd.
General & Plastic Surgery · 188d
Cleared Aug 12, 2022
Tasso+
K221131 · FMK
Tasso, Inc.
General & Plastic Surgery · 116d
Cleared Aug 12, 2022
Unistik® 3, sterile single-use safety lancets
K221126 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 116d
Cleared Aug 12, 2022
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood...
K202739 · NBW
Bioland Technology, Ltd.
Chemistry · 693d
Cleared Aug 10, 2022
Safety Blood Collection Needles with/without Needle Holder
K220900 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared Jul 27, 2022
Upper Arm Type Blood Pressure Monitor
K220886 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 121d
Cleared Jul 15, 2022
Facet 28G Universal Lancet
K221433 · QRK
Facet Technologies, LLC
General & Plastic Surgery · 59d
Cleared Jul 14, 2022
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit...
K220258 · JKA
Avia Vascular
General Hospital · 164d
Cleared Jul 08, 2022
DropSafe Acti-Lance Safety Lancets
K220643 · FMK
Htl-Strefa S.A
General & Plastic Surgery · 126d
Cleared Jul 06, 2022
Lancet (I, II, III, V, VI)
K220475 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 138d
Cleared Jun 30, 2022
Wrist Type Blood Pressure Monitor
K220651 · DXN
Shenzhen Jamr Medical Technology Co.,...
Cardiovascular · 115d
Cleared Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
K220494 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 121d
Cleared Jun 16, 2022
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
K201037 · NBW
Taidoc Technology Corporation
Chemistry · 787d
Cleared Jun 15, 2022
QardioArm 2
K220106 · DXN
Qardio, Inc.
Cardiovascular · 154d
Cleared Jun 09, 2022
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K221368 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 28d
Cleared Jun 08, 2022
Promisemed Heel Blood Lancet
K221371 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 27d
Cleared Jun 05, 2022
Q2 Blood Administration Sets
K213846 · FPA
Quest Medical, Inc.
General Hospital · 177d
Cleared CT Jun 03, 2022
MICROLET NEXT lancing device, MICROLET Lancet
K220633 · QRL
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 91d