Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ekos Corp. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
165 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | Ekos Corp. | 2008-06-26 | 30 | 4 |
| K080392 | EndoWave Infusion System | Ekos Corp. | 2008-04-30 | 77 | 0 |
| K073166 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2008-04-22 | 165 | 0 |
| K072507 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2007-10-04 | 28 | 3 |
| K071933 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2007-08-10 | 28 | 0 |
| K063620 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2007-08-06 | 244 | 0 |
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-12-05 | 99 | 0 |
| K062507 | MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-11-22 | 86 | 0 |
| K060422 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2006-03-09 | 20 | 1 |
| K060084 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2006-02-07 | 27 | 0 |
| K053437 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-01-06 | 28 | 0 |
| K053432 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2005-12-30 | 21 | 0 |
| K052071 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-08-16 | 15 | 0 |
| K051319 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-06-15 | 26 | 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 |
| K050563 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2005-03-29 | 25 | 0 |
| K050472 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-03-11 | 15 | 0 |
| K043269 | Lysus Infusion System | Ekos Corp. | 2004-12-22 | 26 | 0 |
| K042456 | Lysus Infusion System | Ekos Corp. | 2004-09-23 | 13 | 3 |
| K041629 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2004-08-06 | 51 | 0 |
| K033214 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2003-10-14 | 11 | 0 |
| K030637 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2003-07-22 | 144 | 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