Cleared Traditional

K250233 - PreemptiveAI Clinical SDK

K250233 is an FDA 510(k) clearance for PreemptiveAI Clinical SDK, manufactured by Measure Labs, Inc. (Dba Preemptiveai, Inc.). The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 382-day FDA review.

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

FDA 510(k) Submission Details - K250233

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.

DXH Device Classification - Class 2, Special Controls

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 115
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
K250258 · Heartbeam, Inc. · Dec 2025
MEMO Patch M (MPT-E08R-UNC01)
K243438 · Huinno Co., Ltd. · Dec 2025
Hexoskin Medical System (7100-00016)
K243981 · Carre Technologies, Inc. · Nov 2025
VitalSigns 1-Lead Holter (VSH101)
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