Reckitt Benckiser, LLC: FDA clearances and approvals
Reckitt Benckiser, LLC has 9 FDA 510(k) clearances (first 1996, latest 2018), across 3 product codes in 2 review panels. Median 510(k) review time: 186 days. openFDA lists 5 product recalls by a recalling firm named Reckitt Benckiser, LLC. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 420 |
| 2015 | 2 | 196 |
| 2016 | 1 | 186 |
| 2017 | 0 | — |
| 2018 | 1 | 60 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Reckitt Benckiser, LLC's cleared 510(k)s took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUC | Lubricant, Personal | 6 | 6 |
| MED | Sterilant, Medical Devices | 2 | 2 |
| LRJ | Disinfectant, Medical Devices | 1 | 1 |
Review panels
Most recent Reckitt Benckiser, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173504 | K-Y Silicone | NUC | 2018-01-12 | 60 |
| K151884 | K-Y Marilyn Pleasure Gel | NUC | 2016-01-11 | 186 |
| K143532 | Durex Silicone | NUC | 2015-07-31 | 231 |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | NUC | 2015-05-20 | 160 |
| K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT | NUC | 2014-12-17 | 560 |
| K140193 | DUREX EMBRACE PERSONAL LUBRICANT | NUC | 2014-11-04 | 281 |
| K990703 | SPOROX II STERILIZING & DISINFECTING SOLUTION | MED | 1999-03-30 | 26 |
| K970230 | SPOROX | MED | 1997-10-29 | 281 |
| K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) | LRJ | 1996-10-18 | 53 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-12-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Reckitt Benckiser, LLC is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01619397: Evaluation of Tolerance and Acceptability of a Coated Condom (Completed, started 2012-09)
- NCT01536834: Safety & Performance Study of Verruca Treatment Device (Completed, started 2012-06)
- NCT01202279: Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (Completed, started 2009-10)
Frequently asked questions
How many FDA 510(k) clearances does Reckitt Benckiser, LLC have?
Reckitt Benckiser, LLC has 9 FDA 510(k) clearances (first 1996, latest 2018), across 3 product codes in 2 review panels.
How long does FDA take to clear Reckitt Benckiser, LLC's 510(k)s?
The median time from FDA receipt to decision across Reckitt Benckiser, LLC's cleared 510(k)s is 186 days.
What devices does Reckitt Benckiser, LLC make?
Its most frequent FDA product codes are NUC (Lubricant, Personal, 6); MED (Sterilant, Medical Devices, 2); LRJ (Disinfectant, Medical Devices, 1).
Has Reckitt Benckiser, LLC had device recalls?
openFDA lists 5 product recalls in 4 recall events by a recalling firm whose name matches Reckitt Benckiser, LLC; the most recent began 2018-12-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Reckitt Benckiser, LLC clearances with predicates and recalls
- Run predicate analysis for product code NUC, Reckitt Benckiser, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.