EchoNous, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “EchoNous, Inc.” (first 2018, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 98 days, against 101 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 25 |
| 2019 | 0 | — |
| 2020 | 1 | 98 |
| 2021 | 1 | 31 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 272 |
| 2025 | 1 | 262 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name EchoNous, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (5)
Most recent EchoNous, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242321 | Kosmos | IYN | 2025-04-25 | 262 |
| K233826 | Kosmos | IYN | 2024-08-29 | 272 |
| K212100 | Kosmos | IYN | 2021-08-06 | 31 |
| K193518 | KOSMOS | IYN | 2020-03-26 | 98 |
| K181574 | Uscan | IYO | 2018-07-10 | 25 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-05-09.
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.
Device clinical trials
An industry sponsor named EchoNous, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06792851: ECHO-012 Kosmos Bladder Clinical Validation Study (Completed, started 2024-08-05)
- NCT06468787: Kosmos Anatomical Object Labeling and View Identification Pivotal Study (Completed, started 2024-02-07)
- NCT06449872: OB-GYN Clinical Validation Study (Completed, started 2023-10-24)
- NCT06027164: Kosmos Trio and Ejection Fraction Pivotal Study (Completed, started 2023-08-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under EchoNous, Inc.?
FDA lists 5 510(k) clearances under the applicant name “EchoNous, Inc.” (first 2018, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by EchoNous, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name EchoNous, Inc. is 98 days. Since 2017: 98 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under EchoNous, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 5 EchoNous, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, EchoNous, Inc.'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.