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510(k) K151884

K-Y Marilyn Pleasure Gel by Reckitt Benckiser, LLC — Product Code NUC

K151884 is an FDA 510(k) premarket notification submitted by Reckitt Benckiser, LLC for the device "K-Y Marilyn Pleasure Gel". The FDA issued a decision of Substantially Equivalent on January 11, 2016. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Reckitt Benckiser, LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2016
Date Received
July 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Other clearances by Reckitt Benckiser, LLC

  • K173504 — K-Y Silicone (January 12, 2018)
  • K143532 — Durex Silicone (July 31, 2015)
  • K143511 — K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant (May 20, 2015)
  • K131643 — DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT (December 17, 2014)
  • K140193 — DUREX EMBRACE PERSONAL LUBRICANT (November 4, 2014)
  • K990703 — SPOROX II STERILIZING & DISINFECTING SOLUTION (March 30, 1999)
  • K970230 — SPOROX (October 29, 1997)
  • K963353 — LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) (October 18, 1996)

Other clearances for product code NUC

  • K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer (July 9, 2026)
  • K261909 — Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (July 6, 2026)
  • K254011 — Flow Water-Based Personal Lubricant (June 22, 2026)
  • K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (June 11, 2026)
  • K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (June 9, 2026)
  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K254101 — Julva Velvé Water-Based Personal Lubricant (April 16, 2026)
  • K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito (April 1, 2026)
  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)

FDA data resources