Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pjur Group Luxembourg S.A. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
270 daysmedian FDA review time
354 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026-05-21 | 132 | 0 |
| K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOO | Pjur Group Luxembourg S.A. | 2021-02-19 | 354 | 0 |
| K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin | Pjur Group Luxembourg S.A. | 2021-01-21 | 307 | 0 |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glide | Pjur Group Luxembourg S.A. | 2020-12-17 | 272 | 0 |
| K141913 | PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND | Pjur Group Luxembourg S.A. | 2015-04-06 | 265 | 0 |
| K133336 | PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) L | Pjur Group Luxembourg S.A. | 2014-07-24 | 268 | 0 |
| K133233 | PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE | Pjur Group Luxembourg S.A. | 2014-07-18 | 270 | 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