FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

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5,538 results for "blood"
1–24 of 5,538
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Aug 27, 2026
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K260545 · NBW
Ascensia Diabetes Care
Chemistry · 190d
Cleared Aug 26, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus,...
K261394 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 119d
Cleared Aug 25, 2026
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
K262631 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 27d
Cleared Aug 19, 2026
Elecsys Phospho-Tau (217P) Plasma
K261686 · SET
Roche Diagnostics
Immunology · 90d
Cleared Aug 19, 2026
PrecivityAD2 Test
K253240 · SET
C2N Diagnostics, LLC
Immunology · 324d
Cleared Aug 18, 2026
Lancing device
K262135 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Aug 13, 2026
BP Go (BPP-855)
K261061 · DXN
Wellvii, Inc.
Cardiovascular · 135d
Cleared Aug 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor...
K253425 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 316d
Cleared Jul 23, 2026
TRUE METRIX Self Monitoring Blood Glucose System
K262116 · NBW
Trividia Health, Inc.
Chemistry · 30d
Cleared Jul 23, 2026
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
K261136 · DXN
Guangzhou Daxin Health Technology...
Cardiovascular · 107d
Cleared Jul 23, 2026
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
K261082 · DXN
Microlife Corporation
Cardiovascular · 113d
Cleared Jul 22, 2026
Lancet
K262211 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 22d
Cleared Jul 08, 2026
BlueDop Vascular Expert
K260700 · DPW
BlueDop Medical, Ltd.
Cardiovascular · 126d
Cleared Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K260160 · SAN
bioMerieux, Inc.
Microbiology · 169d
Cleared Jul 06, 2026
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
K260122 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 172d
Cleared Jun 26, 2026
PhAST instrument and PhAST Blood Culture Gram-negative Panel
K253316 · SAN
Phast Corp.
Microbiology · 269d
Cleared Jun 22, 2026
Medline Reusable Blood Pressure Cuff
K254287 · DXQ
Medline Industries, LP
Cardiovascular · 173d
Cleared Jun 18, 2026
Blood Volume Analyzer (200)
K261099 · JWO
Daxor Corporation
Hematology · 77d
Cleared Jun 18, 2026
Wrist Blood Pressure Monitor (XW-05)
K253126 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 266d
Cleared Jun 16, 2026
VicorderCS (VCS-SYS-1100)
K260693 · DXN
80 Beats Medical GmbH
Cardiovascular · 105d
Cleared Jun 15, 2026
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
K253059 · DXN
Tournicare Pty, Ltd.
Cardiovascular · 266d
Cleared Jun 12, 2026
Disposable Blood Lancet (Soft)
K261634 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 25d
Cleared Jun 12, 2026
cobas pulse blood glucose monitoring system
K252323 · PZI
Roche Diagnostics
Chemistry · 322d
Cleared Jun 03, 2026
Upper arm electronic blood pressure monitor (XB-01)
K253124 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 251d