Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Software Nemotec S.L. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
226 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232698 | NemoScan | Software Nemotec S.L. | 2024-01-18 | 135 | 0 |
| K232549 | NemoCast | Software Nemotec S.L. | 2023-11-21 | 90 | 0 |
| K193003 | NemoCast | Software Nemotec S.L. | 2020-06-05 | 221 | 0 |
| K192475 | NemoFAB | Software Nemotec S.L. | 2020-04-23 | 226 | 0 |
| K192571 | NemoScan | Software Nemotec S.L. | 2019-12-11 | 84 | 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