INFINITT DPS is an AI-enabled medical device from Infinitt Healthcare Co., Ltd. that the U.S. FDA cleared through 510(k) K243449 on December 9, 2025. Its lead review panel is Pathology and its primary product code is QKQ (Digital Pathology Image Viewing And Management Software).
See also all FDA AI clearances in 2025.
Key facts
| Submission number | K243449 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Infinitt Healthcare Co., Ltd. |
| Lead review panel | Pathology |
| Primary product code | QKQ — Digital Pathology Image Viewing And Management Software |
| Applicant (openFDA) | Infinitt Healthcare Co., Ltd. |
| Applicant location | Seoul, KR |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.3700 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. INFINITT DPS went through this pathway (K243449).
openFDA lists it as a Class 2 device under 21 CFR 864.3700. Class II devices are moderate risk and are subject to general and special controls.
Product code QKQ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Infinitt Healthcare Co., Ltd. has 1 AI-enabled device on the list, and the Pathology panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.