Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mottek Intl. Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
51 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860198 | MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING | Mottek Intl. Corp. | 1986-02-18 | 27 | 0 |
| K855162 | ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR | Mottek Intl. Corp. | 1986-02-12 | 48 | 0 |
| K854932 | ECUMOL ULTRAVIOLET FACE TANNING UNITS | Mottek Intl. Corp. | 1986-01-30 | 51 | 0 |
| K853692 | SUN TANNING BED MODEL EC-3RF | Mottek Intl. Corp. | 1985-10-01 | 27 | 0 |
| K853177 | ECUMOL ULTRAVIOLET SUNTANNNING BEDS | Mottek Intl. Corp. | 1985-08-13 | 14 | 0 |
| K852243 | KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS | Mottek Intl. Corp. | 1985-06-27 | 35 | 0 |
| K852053 | ORIGINAL ULTRAVIOLET SUNTANNING LAMP | Mottek Intl. Corp. | 1985-05-20 | 11 | 0 |
| K843814 | EMUMOL ULTRAVIOLET SUNTANNING LAMP | Mottek Intl. Corp. | 1984-10-25 | 27 | 0 |
| K802134 | JK INT'L, INC. SOLTRON UVA TANNING BED | Mottek Intl. Corp. | 1980-10-23 | 49 | 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