Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QQH — Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | 2026-01-09 | 165 | 0 |
| DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Acces | Iotamotion, Inc. | 2021-10-01 | 653 | 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