Cleared Special

K254004 - VRNT

K254004 is an FDA 510(k) clearance for VRNT, manufactured by Cognifisense, Inc.. The device is a Class 2 Physical Medicine device with product code QRA cleared through the Special 510(k) pathway after a 116-day FDA review.

K254004 · Cognifisense, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
116d
Days
Class 2
Risk

K254004 is an FDA 510(k) clearance for the VRNT. Classified as Virtual Reality Behavioral Therapy Device For Pain Relief (product code QRA), Class II - Special Controls.

Submitted by Cognifisense, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 10, 2026 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5800 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K254004

510(k) Number K254004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date April 10, 2026
Days to Decision 116 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 116d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

QRA Device Classification - Class 2, Special Controls

Product Code QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5800
Definition A Virtual Reality Behavioral Therapy Device For Pain Relief Is A Device Intended To Provide Behavioral Therapy For Patients With Pain. Therapy Is Administered Via A Virtual Reality Display Which Utilizes A Software Program Containing The Behavioral Therapy Content.
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 Physical Medicine devices follow this clearance model.

K254004 · VRNT
Download PDF FDA Summary Cognifisense, Inc.