Not Cleared Direct

DEN240074 - Pulsenmore ES (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240074 · Pulsenmore, Ltd. · Radiology device
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Oct 2025
Decision
324d
Days
Class 2
Risk

DEN240074 is an FDA 510(k) submission (not cleared) for the Pulsenmore ES. Classified as Ultrasound Imaging System For Acquiring Images At Home By Lay Users (product code SGJ), Class II - Special Controls.

Submitted by Pulsenmore, Ltd. (Omer, IL). The FDA issued a Not Cleared (DENG) decision on October 31, 2025 after a review of 324 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1590 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 324 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Pulsenmore, Ltd. devices

Submission Details

510(k) Number DEN240074 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 11, 2024
Decision Date October 31, 2025
Days to Decision 324 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 107d · This submission: 324d
Pathway characteristics

Device Classification

Product Code SGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1590
Definition An Ultrasound Imaging System For Acquiring Images At Home By Lay Users Is A Prescription Home Use Device That May Consist Of Hardware And/or Software Intended For Acquiring Ultrasound Images For Interpretation By A Qualified Health Care Professional (e.g., Fetal Images For Determination Of Fetal Heart Rate). The Device Provides Guidance To Lay Users To Aid Image Acquisition.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.