Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EchoNous, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242321 | Kosmos | EchoNous, Inc. | 2025-04-25 | 262 | 0 |
| K233826 | Kosmos | EchoNous, Inc. | 2024-08-29 | 272 | 0 |
| K212100 | Kosmos | EchoNous, Inc. | 2021-08-06 | 31 | 1 |
| K193518 | KOSMOS | EchoNous, Inc. | 2020-03-26 | 98 | 0 |
| K181574 | Uscan | EchoNous, Inc. | 2018-07-10 | 25 | 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