Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Setma, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
98 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854861 | SETMA HYGIA BATH MODEL ST 7200 | Setma, Inc. | 1986-01-03 | 29 | 0 |
| K854263 | SETMA FHT, MODEL ST 8130 | Setma, Inc. | 1985-11-13 | 21 | 0 |
| K853163 | SETMA VHT | Setma, Inc. | 1985-11-05 | 98 | 0 |
| K841397 | BURN BATH | Setma, Inc. | 1984-05-18 | 45 | 0 |
| K841396 | TRANSFER TROLLEY | Setma, Inc. | 1984-05-07 | 34 | 0 |
| K841395 | SHOWER TROLLEY | Setma, Inc. | 1984-05-07 | 34 | 0 |
| K841398 | VARIABLE HEIGHT TRANSFER CHAIR | Setma, Inc. | 1984-05-07 | 34 | 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