Specialty

FDA-cleared AI hematology devices

The FDA's AI-enabled device list has 22 devices whose lead review panel is Hematology, 1.4% of all 1,614 listed devices. They come from 16 companies. The first decision was on March 15, 2001 and the most recent on April 9, 2026.

22AI devices
11Companies
2001First decision
2026-04-09Latest decision

Guides for hematology

Top hematology AI devices

Trend: devices per year

2001: 12004: 12008: 12010: 12011: 12013: 12017: 12018: 22019: 12020: 32022: 22023: 12024: 12025: 32026: 2
'01'08'11'17'19'22'24'26
FDA-cleared AI hematology devices per year: 2001 1, 2004 1, 2008 1, 2010 1, 2011 1, 2013 1, 2017 1, 2018 2, 2019 1, 2020 3, 2022 2, 2023 1, 2024 1, 2025 3, 2026 2

Top companies

Most common product codes

JOY11 devicesPOV5 devicesGKZ5 devicesLKM1 devices

All 22 devices, newest first

Frequently asked questions

How many FDA-cleared AI hematology devices are there?

As of the FDA list updated through June 29, 2026, 22 AI-enabled devices have Hematology as their lead review panel (1.4% of the list).

Which companies have the most AI hematology devices?

CELLAVISION AB (4), Bonraybio Co., LTD. (2), Athelas Inc. (2) have the most AI-enabled hematology devices on the FDA list.

Which year had the most AI hematology authorizations?

2020 had the most, with 3 devices.

Which FDA pathways are used for AI hematology devices?

510(k): 22.

What was the most recent AI hematology device on the list?

Seaman Pro/Seaman from Checkcells, Inc. (K252228), with a decision dated April 9, 2026.