Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QGL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
263 daysmedian FDA review time
452 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243289 | ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. | 2025-01-16 | 90 | 0 |
| K232991 | BT-1000 | Bistos Co., Ltd. | 2024-08-28 | 341 | 0 |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation | Neurosigma, Inc. | 2024-01-16 | 109 | 0 |
| K213629 | SMILE | Nu Eyne Co., Ltd. | 2023-02-12 | 452 | 0 |
| DEN180041 | Monarch eTNS System | Neurosigma, Inc. | 2019-04-19 | 263 | 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