Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QPL · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
185 daysmedian FDA review time
280 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250309 | BTL-199 | BTL Industries, Inc. | 2025-08-07 | 185 | 0 |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super R | The Magstim Company Limited | 2025-07-03 | 153 | 0 |
| K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025-03-27 | 280 | 0 |
| K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024-01-10 | 100 | 0 |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOpti | Tonica Elektronik A/S | 2023-08-25 | 234 | 0 |
| K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021-06-11 | 158 | 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