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

Filters: Hematology ×
3,297 results
1–24 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 27, 2026
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer...
K260909 · JPA
Sienco, Inc.
Hematology · 222d
Cleared Sep 24, 2026
STA® - Liquid Anti-Xa
K260214 · KFF
Diagnostica Stago, Inc.
Hematology · 244d
Cleared Sep 14, 2026
Yumizen H550
K260781 · GKZ
HORIBA ABX SAS
Hematology · 188d
Cleared Aug 11, 2026
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
K253985 · DAP
Siemens Healthcare Diagnostic...
Hematology · 242d
Cleared Jun 18, 2026
Blood Volume Analyzer (200)
K261099 · JWO
Daxor Corporation
Hematology · 77d
Cleared May 27, 2026
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
K253212 · GKZ
Sysmex America, Inc.
Hematology · 240d
Cleared Apr 27, 2026
STA Satellite Max®
K253658 · JPA
Diagnostica Stago, Inc.
Hematology · 158d
Cleared Apr 09, 2026
Seaman Pro/Seaman
K252228 · POV
Checkcells, Inc.
Hematology · 267d
Cleared Apr 02, 2026
SMART M-CELL Bone Marrow Concentration System
K250518 · QBV
Miracell Co., Ltd.
Hematology · 405d
Cleared Apr 02, 2026
SMART M-CELL PRP Concentration System
K250516 · QBV
Miracell Co., Ltd.
Hematology · 405d
Cleared Mar 20, 2026
HemosIL Factor V Leiden (APC Resistance V)
K260551 · GGW
Instrumentation Laboratory (IL) Co.
Hematology · 30d
Cleared Feb 06, 2026
Athelas Home
K243348 · GKZ
Athelas, Inc.
Hematology · 466d
Cleared Jan 16, 2026
Tru Hematology Test
K251249 · GKZ
Truvian Sciences, Inc.
Hematology · 268d
Cleared Jan 09, 2026
HemosIL Silica Clotting Time
K253957 · GFO
Instrumentation Laboratory (IL) Co.
Hematology · 30d
Cleared Oct 24, 2025
CoaguChek XS Plus System
K253188 · GJS
Roche Diagnostics
Hematology · 28d
Cleared Sep 10, 2025
iQ200 Series
K252580 · LKM
Beckman Coulter, Inc.
Hematology · 26d
Cleared Aug 25, 2025
CRYOcheck Chromogenic Factor VIII
K251440 · GGP
Precision Biologic, Inc.
Hematology · 108d
Cleared Aug 25, 2025
Quantra QStat Cartridge
K251404 · QFR
Hemosonics, LLC
Hematology · 111d
Cleared Aug 04, 2025
Blood Volume Analyzer (200)
K251087 · JWO
Daxor Corporation
Hematology · 117d
Cleared Jul 24, 2025
HemosIL Fibrinogen-C
K251968 · KQJ
Instrumentation Laboratory (IL) Co.
Hematology · 28d
Cleared Jul 21, 2025
microINR System
K251564 · GJS
Iline Microsystems, S.L.
Hematology · 60d
Cleared Jun 27, 2025
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · JOY
Scopio Labs , Ltd.
Hematology · 270d
Cleared Jun 25, 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
K251371 · GKZ
Sysmex America, Inc.
Hematology · 54d
Cleared Jun 25, 2025
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
K250943 · GKZ
Sysmex America, Inc.
Hematology · 89d