Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IMK — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243442 | iBOT® PMD | Mobius Mobility | 2025-01-30 | 85 | 1 |
| K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility | 2021-06-16 | 79 | 0 |
| K172601 | Next Generation iBOT | Deka Research & Development Corp. | 2018-03-02 | 184 | 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