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The Tracker / April 2026 / K254004

510(k) cleared

VRNT

Cognifisense, Inc. · Apr 10, 2026 · K254004

FDA cleared the VRNT from Cognifisense, Inc. on Apr 10, 2026 under K254004, a special 510(k). The device falls under product code QRA, Virtual Reality Behavioral Therapy Device For Pain Relief, regulated at 21 CFR 890.5800 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 15, 2025. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Cognifisense, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254004?

K254004 is the FDA 510(k) for VRNT, submitted by Cognifisense, Inc.. FDA's decision date was Apr 10, 2026, under product code QRA (Virtual Reality Behavioral Therapy Device For Pain Relief).

Who makes the VRNT?

Cognifisense, Inc., based in Sunnyvale, CA, is the applicant of record for K254004.

How long did the K254004 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Apr 10, 2026, 116 days later.

← All decisions in April 2026