510(k) Report

Devices descending from K810310

128 later devices reach K-Y Lubricating Jelly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171855External Moisturizing GelCombe Incorporated20170—
+5K162207Restore Moisturizing Vaginal LubricantGood Clean Love20171—
+5K150841Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal LubricantLaclede, Inc.20151—
+5K150615Vaginal Moisturizing GelCombe Incorporated20151—
+5K150147Lubrigyn creamUniderm Farmaceutici Srl20150—
+6K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC20260—
+6K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.20260—
+6K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories20260—
+6K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.20260—
+6K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…Hudi Pharma Srl20260—
+6K251011Chiavaye Personal MoisturizerUnipack, LLC20250—
+6K250629Sutil Rich Personal LubricantHathor Professional Skincare, Ltd.20250—
+6K242958Joylux Intimacy Gel (PG3100)Joylux, Inc.20250—
+6K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd.20251—
+6K240081Human LubricantJiangxi Wulinxiang Biological Technology Co., Ltd.20241—
+6K230518HydraDose Vaginal SuppositoriesMD Labs, LLC20230—
+6K222175Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc..20222—
+6K221829Wet Flavored Personal LubricantsTrigg Laboratories, Inc.20220—
+6K202667Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc.20210—
+6K192204Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva…Valencia Naturals, Inc.20190—
+6K190150Sage 2-in-1 Personal Lubricant and MoisturizerFairhaven Health, LLC20190—
+6K180014Creme de La Femme Feminine LubricantCewal, Inc. Dba Premiere Enterprises20180—
+6K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…United Consortium20180—
+6K162235Luvena Vaginal Moisturizer & LubricantLaclede, Inc.20170—
+7K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)20260—
+7K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd.20260—
+7K251773Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel…Shenzhen Yongquan Medical Devices Co., Ltd.20250—
+7K232093Woo More Play Coconut Love OilWoo Essentials, Inc.20230—