PreemptiveAI Clinical SDK
K-Number: K250233 · 2026-02-13
Decision Date2026-02-13
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PreemptiveAI Clinical SDK is a medical device manufactured by Measure Labs, Inc. (Dba Preemptiveai, Inc.). It received FDA 510(k) clearance on 2026-02-13 under approval 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.
Frequently Asked Questions
What is the PreemptiveAI Clinical SDK?
PreemptiveAI Clinical SDK is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Measure Labs, Inc. (Dba Preemptiveai, Inc.). The 510(k) number is K250233.
When was PreemptiveAI Clinical SDK approved by the FDA?
PreemptiveAI Clinical SDK received FDA 510(k) clearance on 2026-02-13, under approval number K250233.
What company makes PreemptiveAI Clinical SDK?
PreemptiveAI Clinical SDK is manufactured by Measure Labs, Inc. (Dba Preemptiveai, Inc.).
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.
Related Devices (Code: DXH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.