Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Hematology — Predicate Candidate Screening
4,194 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
115 daysmedian FDA review time
344 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260755 | OptraSCAN System | Optrascan, Inc. | 2026-07-02 | 115 | 0 |
| K261099 | Blood Volume Analyzer (200) | Daxor Corporation | 2026-06-18 | 77 | 0 |
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | 2026-05-27 | 240 | 0 |
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026-04-27 | 158 | 0 |
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | 2026-04-09 | 267 | 0 |
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | 2026-03-20 | 30 | 0 |
| K243348 | Athelas Home | Athelas, Inc. | 2026-02-06 | 466 | 0 |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 2026-01-16 | 268 | 0 |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | 2026-01-09 | 30 | 0 |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025-10-24 | 28 | 0 |
| DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | 2025-09-19 | 301 | 0 |
| K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025-09-10 | 26 | 0 |
| K251404 | Quantra QStat Cartridge | Hemosonics, LLC | 2025-08-25 | 111 | 0 |
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025-08-25 | 108 | 0 |
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | 2025-08-04 | 117 | 0 |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | 2025-07-24 | 28 | 0 |
| K251564 | microINR System | Iline Microsystems, S.L. | 2025-07-21 | 60 | 0 |
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) App | Scopio Labs , Ltd. | 2025-06-27 | 270 | 0 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 | 89 | 0 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 | 54 | 0 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | 2025-06-02 | 63 | 0 |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE | Bonraybio Co., Ltd. | 2025-05-30 | 253 | 0 |
| DEN240035 | ConcizuTrace™ ELISA | Randox Laboratories, Ltd. | 2025-05-22 | 325 | 0 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025-05-09 | 270 | 0 |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2025-05-02 | 214 | 0 |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartr | Haemonetics | 2025-04-30 | 28 | 0 |
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 | 184 | 0 |
| K243543 | microINR System | Iline Microsystems, S.L. | 2025-02-27 | 104 | 0 |
| K250218 | Xpert® FII & FV | Cepheid | 2025-02-21 | 28 | 0 |
| K243283 | Alinity h-series System | Abbott Laboratories | 2025-02-20 | 126 | 1 |
| K240402 | Cito CBC System | Cytochip, Inc. | 2025-02-03 | 360 | 0 |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | 2025-01-28 | 90 | 0 |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartr | Haemonetics Corporation | 2025-01-15 | 30 | 0 |
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507 | Ventana Medical Systems, Inc. | 2024-12-05 | 190 | 0 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2024-11-29 | 176 | 0 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-22 | 931 | 0 |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OP | Siemens Healthcare Diagnostics Products GmbH | 2024-10-10 | 251 | 0 |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL | Instrumentation Laboratory (IL) Co. | 2024-08-16 | 28 | 0 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH | Beckman Coulter, Inc. | 2024-07-05 | 157 | 2 |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | 2024-05-21 | 244 | 0 |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | 2024-05-03 | 266 | 0 |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | 2024-05-02 | 57 | 0 |
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent St | Urit Medical Electronic Co., Ltd. | 2024-04-26 | 267 | 0 |
| K240182 | Access EPO | Beckman Coulter, Inc. | 2024-04-22 | 90 | 0 |
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | 2024-04-04 | 272 | 0 |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | 2024-03-29 | 266 | 0 |
| K240045 | QStat Cartridge | Hemosonics, LLC | 2024-03-27 | 82 | 0 |
| DEN230034 | X100 with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. | 2024-03-22 | 329 | 0 |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | 2024-03-15 | 358 | 0 |
| DEN230024 | Technozym ADAMTS13 Activity | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | 2024-02-28 | 328 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda