Cleared Traditional

K253840 - STEDI Scan Device

K253840 is the FDA 510(k) clearance for STEDI Scan Device by Stroke DX. It is a Class 2 Neurology device (product code QAF) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K253840 · Stroke DX · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
233d
Days
Class 2
Risk

K253840 is an FDA 510(k) clearance for the STEDI Scan Device. Classified as Impedance Plethysmograph, Cranial (product code QAF), Class II - Special Controls.

Submitted by Stroke DX (Culver City, US). The FDA issued a Cleared decision on July 22, 2026 after a review of 233 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2770 - the FDA neurology device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stroke DX devices

Submission Details

510(k) Number K253840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2025
Decision Date July 22, 2026
Days to Decision 233 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 148d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAF Impedance Plethysmograph, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
Definition Detect Or Measure Variations In Volume In The Cranium, Using Tissue Impedance Properties.
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 Neurology devices follow this clearance model.