Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Etiometry, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
303 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254066 | Etiometry Platform | Etiometry, Inc. | 2026-04-03 | 106 | 0 |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025-02-12 | 264 | 0 |
| K223578 | T3 Platform software | Etiometry, Inc. | 2023-07-07 | 219 | 0 |
| K213423 | T3 Platform software | Etiometry, Inc. | 2023-01-06 | 443 | 0 |
| K213230 | T3 Platform Software | Etiometry, Inc. | 2022-06-22 | 266 | 0 |
| K202306 | T3 Platform software | Etiometry, Inc. | 2020-11-25 | 103 | 0 |
| K190273 | T3 Platform software | Etiometry, Inc. | 2019-12-08 | 303 | 0 |
| K163065 | T3 Software | Etiometry, Inc. | 2017-05-26 | 205 | 0 |
| K152258 | T3 Software | Etiometry, Inc. | 2016-03-31 | 233 | 0 |
| K151715 | T3 Software | Etiometry, Inc. | 2015-10-29 | 126 | 0 |
| K142732 | T3 Software | Etiometry, Inc. | 2015-03-04 | 162 | 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