Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
E-Scopics — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260748 | ES-Series | E-Scopics | 2026-06-09 | 95 | 0 |
| K260589 | ES-Series | E-Scopics | 2026-04-29 | 68 | 0 |
| K232336 | ES Series V2 | E-Scopics | 2023-09-26 | 53 | 0 |
| K213102 | ES1 System | E-Scopics | 2022-01-11 | 109 | 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