Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NUI · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-12-05 | 99 | 0 |
| K053437 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-01-06 | 28 | 0 |
| K051225 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2005-06-10 | 29 | 0 |
| K041826 | EKOS ULTRASOUND INFUSION SYSTEM | Ekos Corp. | 2005-04-27 | 294 | 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