Mottek Intl. Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Mottek Intl. Corp.” (first 1980, latest 1986), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 27 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 8 | 8 |
| LEJ | Booth, Sun Tan | 1 | 1 |
Review panels
Most recent Mottek Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860198 | MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING | FTC | 1986-02-18 | 27 |
| K855162 | ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR | FTC | 1986-02-12 | 48 |
| K854932 | ECUMOL ULTRAVIOLET FACE TANNING UNITS | FTC | 1986-01-30 | 51 |
| K853692 | SUN TANNING BED MODEL EC-3RF | FTC | 1985-10-01 | 27 |
| K853177 | ECUMOL ULTRAVIOLET SUNTANNNING BEDS | FTC | 1985-08-13 | 14 |
| K852243 | KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS | FTC | 1985-06-27 | 35 |
| K852053 | ORIGINAL ULTRAVIOLET SUNTANNING LAMP | FTC | 1985-05-20 | 11 |
| K843814 | EMUMOL ULTRAVIOLET SUNTANNING LAMP | FTC | 1984-10-25 | 27 |
| K802134 | JK INT'L, INC. SOLTRON UVA TANNING BED | LEJ | 1980-10-23 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Mottek Intl. Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mottek Intl. Corp.?
FDA lists 9 510(k) clearances under the applicant name “Mottek Intl. Corp.” (first 1980, latest 1986), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mottek Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mottek Intl. Corp. is 27 days.
Which FDA product codes appear under Mottek Intl. Corp.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 8); LEJ (Booth, Sun Tan, 1).
Next steps
- See all 9 Mottek Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Mottek Intl. Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.