FDA 510(k)

PreemptiveAI Clinical SDK

N.º K: K250233 · 2026-02-13

SolicitanteMeasure Labs, Inc. (Dba Preemptiveai, Inc.)

Fecha de decisión2026-02-13

Código de productoDXH

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PreemptiveAI Clinical SDK is the device name listed in this FDA 510(k) record. The listed applicant is Measure Labs, Inc. (Dba Preemptiveai, Inc.). It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K250233. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PreemptiveAI Clinical SDK?

PreemptiveAI Clinical SDK is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Measure Labs, Inc. (Dba Preemptiveai, Inc.). The 510(k) number is K250233.

When did PreemptiveAI Clinical SDK receive FDA 510(k) clearance?

PreemptiveAI Clinical SDK received FDA 510(k) clearance on 2026-02-13, under 510(k) number K250233.

Who is the listed applicant for PreemptiveAI Clinical SDK?

The FDA 510(k) record lists Measure Labs, Inc. (Dba Preemptiveai, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreemptiveAI Clinical SDK?

The FDA product code for PreemptiveAI Clinical SDK is DXH. This falls under the Hematology category.

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