Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OKJ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | 2025-09-23 | 89 | 0 |
| K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-09-05 | 133 | 0 |
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022-10-07 | 74 | 0 |
| DEN090012 | VIRULITE COLD SORE MACHINE | Virulite, LLC | 2012-10-18 | 1206 | 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