510(k) · Cleared
ClearedVRNT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cognifisense, Inc. · QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Cleared on Apr 10, 2026 as substantially equivalent to K230814 (Cognifisense, Inc., 2023) after a 116-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Apr 10, 2026
- Review
- 116 days
- Class
- Class II
- Product code
- QRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN210014 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRA device
- #1 K243417 RelieVRxscore 11.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230814 | VRNTSummary page 5…Product Code: QRA Regulation Number: 21 CFR 890.5800 Panel: Neurology Predicate Device: VRNT (K230814) Reason for submission: Device Modification Device Description VRNT is an immersive virtual reality (VR) system wh… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QRA devicesQRA Virtual Reality Behavioral Therapy Device For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRA
Too few QRA 510(k)s in any year since 2007 to give a median.
Recalls per year · QRA
No recall names QRA since 2007.
Adverse event reports per year · QRA
No MAUDE report names QRA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VRNT is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months).
The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254004 · printed Nov 5, 2026
Cite this page
510(k) Report. “K254004: VRNT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K254004
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026