Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immersivetouch — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230249 | Ikshana | Immersivetouch | 2023-10-16 | 259 | 0 |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | 2020-06-09 | 704 | 0 |
| K140860 | ImmersiveTouch3 and MicrovisTouch | Immersivetouch | 2014-12-16 | 257 | 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