Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EHO · 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) |
|---|---|---|---|---|---|
| K934468 | SLIP-ON FIXATION SPLINT (SFS) | Gatewood Splints | 1994-08-05 | 329 | 0 |
| K881133 | 70-X/RVG (RADIOVISIOGRAPHY) | Trophy Radiologie | 1989-07-20 | 491 | 0 |
| K883388 | DENTREK BRIDGE BARS | Dale T. Dupuis | 1988-10-06 | 57 | 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