Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SDO — 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) |
|---|---|---|---|---|---|
| K253638 | xStep (xStep) | Spinex, Inc. | 2026-04-20 | 152 | 0 |
| K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation | Aneuvo | 2026-03-27 | 197 | 0 |
| K251821 | ARC-EX System | Onward Medical, Inc. | 2025-11-14 | 154 | 0 |
| DEN240014 | ARC-EX System | Onward Medical, Inc. | 2024-12-19 | 266 | 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