Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reckitt Benckiser, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
231 daysmedian FDA review time
560 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173504 | K-Y Silicone | Reckitt Benckiser, LLC | 2018-01-12 | 60 | 0 |
| K151884 | K-Y Marilyn Pleasure Gel | Reckitt Benckiser, LLC | 2016-01-11 | 186 | 0 |
| K143532 | Durex Silicone | Reckitt Benckiser, LLC | 2015-07-31 | 231 | 0 |
| K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT | Reckitt Benckiser, LLC | 2014-12-17 | 560 | 0 |
| K140193 | DUREX EMBRACE PERSONAL LUBRICANT | Reckitt Benckiser, LLC | 2014-11-04 | 281 | 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