Cleared Traditional

K252923 - IASIS i2 Relaxation Neurofeedback System (FDA 510(k) Clearance)

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

Submission Details

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

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.