Cleared Traditional

K252923 - IASIS i2 Relaxation Neurofeedback System

K252923 · Iasis Technologies · Neurology device
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Mar 2026
Decision
179d
Days
-
Risk

K252923 is an FDA 510(k) clearance for the IASIS i2 Relaxation Neurofeedback System.

Submitted by Iasis Technologies (Murrieta, US). The FDA issued a Cleared decision on March 13, 2026 after a review of 179 days - an extended review cycle.

This device falls under the Neurology FDA review panel. 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 Iasis Technologies devices

FDA 510(k) Submission Details - K252923

510(k) Number K252923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date March 13, 2026
Days to Decision 179 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 148d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -

Regulatory Consultant

Mdi Consultants, Inc.
Vaibhav Rajal

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.