Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
SDJ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025-06-20 | 150 | 0 |
| K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | 2025-05-21 | 155 | 0 |
| K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024-11-15 | 232 | 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