Appliedvr: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Appliedvr” (first 2024, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 30 |
| 2025 | 1 | 89 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Appliedvr took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QRA | Virtual Reality Behavioral Therapy Device For Pain Relief | 3 | 2 |
Review panels
Most recent Appliedvr 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251519 | RelieVRx (Pico G3) | QRA | 2025-08-13 | 89 |
| K243417 | RelieVRx | QRA | 2024-12-04 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210014 | De Novo | Virtual Reality Behavioral Therapy Device For Pain Relief | 2021-11-16 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-02-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Appliedvr is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05263037: EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain (Active not recruiting, started 2022-01-31)
- NCT04010266: RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use (Completed, started 2021-03-01)
- NCT04139564: EaseVRx for the Reduction of Chronic Pain and Opioid Use (Completed, started 2021-01-11)
- NCT04415177: Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain (Completed, started 2020-07-01)
- NCT04345575: Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain (Completed, started 2019-03-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Appliedvr?
FDA lists 2 510(k) clearances under the applicant name “Appliedvr” (first 2024, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Appliedvr?
The median time from FDA receipt to decision across 510(k)s cleared under the name Appliedvr is 60 days.
Which FDA product codes appear under Appliedvr?
The most frequent FDA product codes under this applicant name are QRA (Virtual Reality Behavioral Therapy Device For Pain Relief, 3).
Next steps
- See all 2 Appliedvr clearances with predicates and recalls
- Run predicate analysis for product code QRA, Appliedvr's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.