Pjur Group Luxembourg S.A.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pjur Group Luxembourg S.A.” (first 2014, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 270 days. Since 2017 the median was 290 days, against 140 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 2 | 269 |
| 2015 | 1 | 265 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 272 |
| 2021 | 2 | 330 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pjur Group Luxembourg S.A. took a median 290 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUC | Lubricant, Personal | 7 | 7 |
Review panels
Most recent Pjur Group Luxembourg S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260068 | pjur NATURE Touch, 100 ml | NUC | 2026-05-21 | 132 |
| K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur | NUC | 2021-02-19 | 354 |
| K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 | NUC | 2021-01-21 | 307 |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glide | NUC | 2020-12-17 | 272 |
| K141913 | PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! | NUC | 2015-04-06 | 265 |
| K133336 | PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE | NUC | 2014-07-24 | 268 |
| K133233 | PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE | NUC | 2014-07-18 | 270 |
Recalls
openFDA lists no recalls under a recalling firm named Pjur Group Luxembourg S.A..
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 Pjur Group Luxembourg S.A.?
FDA lists 7 510(k) clearances under the applicant name “Pjur Group Luxembourg S.A.” (first 2014, latest 2026), across 1 product code 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 Pjur Group Luxembourg S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pjur Group Luxembourg S.A. is 270 days. Since 2017: 290 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pjur Group Luxembourg S.A.?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 7).
Next steps
- See all 7 Pjur Group Luxembourg S.A. clearances with predicates and recalls
- Run predicate analysis for product code NUC, Pjur Group Luxembourg S.A.'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.