Cleared Traditional

K250233 - PreemptiveAI Clinical SDK (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K250233 · Measure Labs, Inc. (Dba Preemptiveai, Inc.) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
382d
Days
Class 2
Risk

K250233 is an FDA 510(k) clearance for the PreemptiveAI Clinical SDK. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Measure Labs, Inc. (Dba Preemptiveai, Inc.) (Seattle, US). The FDA issued a Cleared decision on February 13, 2026 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Measure Labs, Inc. (Dba Preemptiveai, Inc.) devices

Submission Details

510(k) Number K250233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2025
Decision Date February 13, 2026
Days to Decision 382 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 125d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

RQM+
Matt Whitehill

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT06696339 Active not recruiting Observational Industry-sponsored

Assessment of Heart Rate Measurement Accuracy for the PreemptiveAI SDK in Adults

Collection of Fingertip Video for Determination of Heart Rate

100
Patients (est.)
1
Site
Condition studied Heart Rate in the General Public
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor PreemptiveAI, Inc (industry)
Started 2024-10-03 → Primary completion 2024-11-15 → Completed 2025-03-01
Primary outcome
Heart Rate Error
View full study on ClinicalTrials.gov

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 296
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K250233.
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
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K243003 · VitalSigns Technology Co., Ltd. · Jun 2025
QT ECG (QTERD100)
K233521 · QT Medical, Inc. · Dec 2023
V-Patch Cardiac Monitor
K222842 · Shandong Corecare Technology Limited · Oct 2022