Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sun Shanty, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832482 | COMBO UVB/UVA TANNING BOOTHS 8-40-12-36 | Sun Shanty, Inc. | 1984-04-24 | 281 | 0 |
| K837032 | UVB LIGHT BOX TANNING BOOTH | Sun Shanty, Inc. | 1983-01-27 | 64 | 0 |
| K813307 | UVA HEX UNIT | Sun Shanty, Inc. | 1981-12-31 | 38 | 0 |
| K792500 | UVB LIGHT BOX - UVB LIGHT BOOTH | Sun Shanty, Inc. | 1980-02-19 | 77 | 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