Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Etac Us, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
234 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923428 | PANDA | Etac Us, Inc. | 1993-03-04 | 234 | 0 |
| K914610 | SWEDE CROSS MANUAL WHEELCHAIR | Etac Us, Inc. | 1991-11-29 | 43 | 0 |
| K883275 | SWEDE ELITE, MECHANICAL WHEELCHAIR | Etac Us, Inc. | 1988-08-18 | 15 | 0 |
| K875034 | SWEDE CHAMP (WHEELCHAIR) | Etac Us, Inc. | 1988-01-12 | 36 | 0 |
| K875035 | SWEDE PETITE (WHEELCHAIR) | Etac Us, Inc. | 1988-01-12 | 36 | 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