Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QRA — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
185 daysmedian FDA review time
231 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254004 | VRNT | Cognifisense, Inc. | 2026-04-10 | 116 | 0 |
| K251519 | RelieVRx (Pico G3) | Appliedvr | 2025-08-13 | 89 | 0 |
| K243417 | RelieVRx | Appliedvr | 2024-12-04 | 30 | 0 |
| K230814 | VRNT | Cognifisense, Inc. | 2023-10-31 | 221 | 0 |
| K230825 | Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. | 2023-09-25 | 185 | 0 |
| DEN210014 | EaseVRx | Appliedvr, Inc. | 2021-11-16 | 231 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda