# FDA Hematology device clearances: 42 since Nov 2024

Updated October 27, 2026.

FDA made 42 device decisions in hematology (FDA review panel) from November 22, 2024 to October 27, 2026: 41 510(k) clearances and De Novo grants and 1 PMA approvals and supplements, for 30 applicants. The newest, K260909 on October 27, 2026, is Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1)... from Sienco, Inc..

## The full list

FDA hematology device clearances and approvals: 42 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 1 row a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/panel/hematology

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 42
- 510(k) and De Novo: 41
- PMA: 1
- Latest decision: October 27, 2026

## Newest decisions

The newest 42 of 42, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 27, 2026 | K260909 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation &... | Sienco, Inc. | Colorado | Substantially Equivalent | 510(k) special | JPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260909) |
| October 20, 2026 | K260215 | BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color \[4-2-2\], 10-color \[4-3-3\]... | Bd Biosciences | California | Substantially Equivalent | 510(k) traditional | PWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260215) |
| September 24, 2026 | K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | New Jersey | Substantially Equivalent | 510(k) special | KFF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260214) |
| September 14, 2026 | K260781 | Yumizen H550 | Horiba Abx Sas | France | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260781) |
| August 11, 2026 | K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | Germany | Substantially Equivalent | 510(k) traditional | DAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253985) |
| July 2, 2026 | K260755 | OptraSCAN System | Optrascan, Inc. | California | Substantially Equivalent | 510(k) traditional | NOT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260755) |
| June 18, 2026 | K261099 | Blood Volume Analyzer (200) | Daxor Corporation | Tennessee | Substantially Equivalent | 510(k) special | JWO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261099) |
| May 27, 2026 | K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253212) |
| April 27, 2026 | K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | New Jersey | Substantially Equivalent | 510(k) traditional | JPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253658) |
| April 9, 2026 | K252228 | Seaman Pro/Seaman | Checkcells, Inc. | California | Substantially Equivalent | 510(k) traditional | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252228) |
| March 20, 2026 | K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | Massachusetts | Substantially Equivalent | 510(k) special | GGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260551) |
| February 6, 2026 | K243348 | Athelas Home | Athelas, Inc. | California | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243348) |
| January 16, 2026 | K251249 | Tru Hematology Test | Truvian Sciences, Inc. | California | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251249) |
| January 9, 2026 | K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | Massachusetts | Substantially Equivalent | 510(k) special | GFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253957) |
| October 24, 2025 | K253188 | CoaguChek XS Plus System | Roche Diagnostics | Indiana | Substantially Equivalent | 510(k) special | GJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253188) |
| September 19, 2025 | DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | United Kingdom | Unknown | De Novo | SFS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240067) |
| September 10, 2025 | K252580 | iQ200 Series | Beckman Coulter, Inc. | Florida | Substantially Equivalent | 510(k) special | LKM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252580) |
| August 25, 2025 | K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | Canada | Substantially Equivalent | 510(k) traditional | GGP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251440) |
| August 25, 2025 | K251404 | Quantra QStat Cartridge | Hemosonics, LLC | North Carolina | Substantially Equivalent | 510(k) traditional | QFR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251404) |
| August 4, 2025 | K251087 | Blood Volume Analyzer (200) | Daxor Corporation | Tennessee | Substantially Equivalent | 510(k) traditional | JWO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251087) |
| July 24, 2025 | P250002 | Quest Diagnostics AAVrh74 Antibody ELISA CDx | Quest Diagnostics Nichols Institute | California | Approved | PMA original approval | QWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250002) |
| July 24, 2025 | K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | Massachusetts | Substantially Equivalent | 510(k) special | KQJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251968) |
| July 21, 2025 | K251564 | microINR System | Iline Microsystems, S.L. | Spain | Substantially Equivalent | 510(k) traditional | GJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251564) |
| June 27, 2025 | K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | Israel | Substantially Equivalent | 510(k) traditional | JOY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243144) |
| June 25, 2025 | K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251371) |
| June 25, 2025 | K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250943) |
| June 2, 2025 | K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | JPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250965) |
| May 30, 2025 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242830) |
| May 22, 2025 | DEN240035 | ConcizuTrace™ ELISA | Randox Laboratories, Ltd. | United Kingdom | Unknown | De Novo | SES | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240035) |
| May 9, 2025 | K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242388) |
| May 2, 2025 | K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | Israel | Substantially Equivalent | De Novo (dual track) | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243114) |
| April 30, 2025 | K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | Massachusetts | Substantially Equivalent | 510(k) special | JPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251024) |
| March 28, 2025 | K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | Germany | Substantially Equivalent | 510(k) traditional | JBQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242952) |
| February 27, 2025 | K243543 | microINR System | Iline Microsystems, S.L. | Spain | Substantially Equivalent | 510(k) traditional | GJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243543) |
| February 21, 2025 | K250218 | Xpert® FII & FV | Cepheid | California | Substantially Equivalent | 510(k) special | NPR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250218) |
| February 20, 2025 | K243283 | Alinity h-series System | Abbott Laboratories | California | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243283) |
| February 3, 2025 | K240402 | Cito CBC System | Cytochip, Inc. | California | Substantially Equivalent | De Novo (dual track) | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240402) |
| January 28, 2025 | K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | Massachusetts | Substantially Equivalent | 510(k) traditional | LCO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243374) |
| January 15, 2025 | K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | Massachusetts | Substantially Equivalent | 510(k) special | JPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243858) |
| December 5, 2024 | DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Ventana Medical Systems, Inc. | Arizona | Unknown | De Novo | SDP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240025) |
| November 29, 2024 | K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | Israel | Substantially Equivalent | 510(k) traditional | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241628) |
| November 22, 2024 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Massachusetts | Substantially Equivalent | De Novo (dual track) | LCP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221326) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Sysmex America, Inc. | 4 | May 27, 2026 |
| Instrumentation Laboratory (IL) Co. | 4 | March 20, 2026 |
| Diagnostica Stago, Inc. | 2 | September 24, 2026 |
| Siemens Healthcare Diagnostic Products GmbH | 2 | August 11, 2026 |
| Daxor Corporation | 2 | June 18, 2026 |
| Iline Microsystems, S.L. | 2 | July 21, 2025 |
| Bonraybio Co., Ltd. | 2 | May 30, 2025 |
| Medical Electronic Systems , Ltd. | 2 | May 2, 2025 |
| Sienco, Inc. | 1 | October 27, 2026 |
| Bd Biosciences | 1 | October 20, 2026 |
| Horiba Abx Sas | 1 | September 14, 2026 |
| Optrascan, Inc. | 1 | July 2, 2026 |
| Checkcells, Inc. | 1 | April 9, 2026 |
| Athelas, Inc. | 1 | February 6, 2026 |
| Truvian Sciences, Inc. | 1 | January 16, 2026 |
| Roche Diagnostics | 1 | October 24, 2025 |
| Cytocell Limited | 1 | September 19, 2025 |
| Beckman Coulter, Inc. | 1 | September 10, 2025 |
| Precision Biologic, Inc. | 1 | August 25, 2025 |
| Hemosonics, LLC | 1 | August 25, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 24 | October 20, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 11 | October 27, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 3 | September 19, 2025 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 3 | May 2, 2025 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 1 | July 24, 2025 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 9 | October 20, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 7 | March 20, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 4 | May 27, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 3 | June 27, 2025 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 2 | September 24, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 2 | August 11, 2026 |
| [Tennessee](https://specstream.ai/data/fda-clearances/state/tennessee) | 2 | June 18, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 2 | September 19, 2025 |
| [Spain](https://specstream.ai/data/fda-clearances/country/spain) | 2 | July 21, 2025 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 2 | May 30, 2025 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 1 | October 27, 2026 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 1 | September 14, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 1 | October 24, 2025 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 1 | September 10, 2025 |
| [Canada](https://specstream.ai/data/fda-clearances/country/canada) | 1 | August 25, 2025 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 1 | August 25, 2025 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 1 | December 5, 2024 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).