Ekos Corp.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Ekos Corp.” (first 2003, latest 2020), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 158 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ekos Corp. took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 19 | 19 |
| NUI | Ultrasound, Infusion, System | 4 | 4 |
| DRA | Catheter, Steerable | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Cardiovascular (21)
- Neurology (4)
Most recent Ekos Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | QEY | 2020-08-17 | 158 |
| K111705 | EKOSONIC ENDOVASCULAR SYSTEM | QEY | 2011-08-03 | 47 |
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | QEY | 2008-06-26 | 30 |
| K080392 | EndoWave Infusion System | QEY | 2008-04-30 | 77 |
| K073166 | ENDOWAVE INFUSION SYSTEM | KRA | 2008-04-22 | 165 |
| K072507 | ENDOWAVE INFUSION SYSTEM | QEY | 2007-10-04 | 28 |
| K071933 | ENDOWAVE INFUSION SYSTEM | QEY | 2007-08-10 | 28 |
| K063620 | EKOS MICRO-INFUSION SYSTEM | QEY | 2007-08-06 | 244 |
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | NUI | 2006-12-05 | 99 |
| K062507 | MICRO-INFUSION SYSTEM | QEY | 2006-11-22 | 86 |
15 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 14 recall events; 0 initiated in the last five years. Most recent: 2016-08-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ekos Corp.?
FDA lists 25 510(k) clearances under the applicant name “Ekos Corp.” (first 2003, latest 2020), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ekos Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ekos Corp. is 28 days.
Which FDA product codes appear under Ekos Corp.?
The most frequent FDA product codes under this applicant name are QEY (Mechanical Thrombolysis Catheter, 19); NUI (Ultrasound, Infusion, System, 4); DRA (Catheter, Steerable, 1).
Next steps
- See all 25 Ekos Corp. clearances with predicates and recalls
- Run predicate analysis for product code QEY, Ekos Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.