Company ยท US
Reckitt Benckiser, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2018. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2018 | K173504 | K-Y Silicone Reckitt Benckiser, LLC | NUC |
| Jan 11, 2016 | K151884 | K-Y Marilyn Pleasure Gel Reckitt Benckiser, LLC | NUC |
| Jul 31, 2015 | K143532 | Durex Silicone Reckitt Benckiser, LLC | NUC |
| May 20, 2015 | K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant Reckitt Benckiser | NUC |
| Dec 17, 2014 | K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT Reckitt Benckiser, LLC | NUC |
| Nov 4, 2014 | K140193 | DUREX EMBRACE PERSONAL LUBRICANT Reckitt Benckiser, LLC | NUC |
| Mar 30, 1999 | K990703 | SPOROX II STERILIZING & DISINFECTING SOLUTION Reckitt Benckiser, Inc. | MED |
| Oct 29, 1997 | K970230 | SPOROX Reckitt Benckiser, Inc. | MED |
| Oct 18, 1996 | K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) Reckitt Benckiser, Inc. | LRJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2019 | Reckitt Benckiser LLC Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00 Terminated |
MOL | K072169 |
| Mar 9, 2019 | Reckitt Benckiser LLC Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14
02340-89455-00
02340-89456-14
02340-89456-14
02340-89455-00
02340-95767-00
02340-89456-14
02340-89457-00
02340-89456-14
02340-894 Terminated |
MOL | K072169 |
| Aug 6, 2018 | Reckitt Benckiser LLC Polyisoprene condomns
Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually t Terminated |
MOL | K072169 |
| Jul 23, 2018 | Reckitt Benckiser LLC Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00
Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and fo Terminated |
MOL | K072169 |
| Nov 22, 2016 | Reckitt Benckiser LLC Durex Pleasure Pack .
3 ultra fine lubricated latex condoms
12 ultra fine lubricated latex condoms
24 Ra fine lubricated latex condoms
3 ct UPC 3-02340-30042-04-1
3 ct - Walmart UPC 02340-70042- Terminated |
HIS | None listed |