510(k) Report

Devices descending from K955648

95 later devices reach K-Y Personal Lubricant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151884K-Y Marilyn Pleasure GelReckitt Benckiser, LLC20163—
+1K110325Aqua LubeMayer Laboratories, Inc.20112—
+1K091554Pharmapac Personal LubricantPharmapac, LLC20090—
+1K070587Elegance Woman's LubricantJulie Williams, Pa-C200811—
+1K071626Durex Play Soft & Sensual LubricantSsl Americas20080—
+1K063385Durex Play Massage Gel LubricantSsl Americas, Inc.20080—
+1K061466IntimolDlc Laboratories, Inc.200624—
+1K051688For Play, Slip, Prepair - Personal LubricantsTrimensa Pharmaceuticals20063—
+1K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc.200622—
+1K052162Sheffield Brand Warming Lubrigel Personal LubricantSheffield Laboratories, Div. of Faria Limited, LLC20062—
+1K042958Durex Play Tingling LubricantSsl Americas, Inc.20050—
+1K042563Durex Play Warmer LubricantSsl Americas, Inc.200524—
+1K032124Durex Play LubricantSsl Americas, Inc.200440—
+1K033076Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc.200317—
+1K982673Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic199818—
+2K183505KY Banksy MoistureRb Health (Us), LLC20191—
+2K180828Natureplex Warm Touch Warming JellyNatureplex, LLC20180—
+2K180136BioNude LubricantGood Clean Love, Inc.20180—
+2K163674Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens…Neo Cosmetique20170—
+2K151857Love Alchemy's Love LotionLove Alchemy, LLC20170—
+2K150841Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal LubricantLaclede, Inc.20151—
+2K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A.20159—
+2K124044Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc.201323—
+2K122476Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC201313—
+2K122054Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC20136—
+2K120650Poise Personal LubricantKimberly-Clark Corporation20121—
+2K072236Durex Play Tingling Aqueous Based LubricantSsl Americas20080—
+2K033776Instead Intimate LubricantInstead, Inc.200417—
+3K221243OFNat Lubricant (L15)Suretex Limited20220—
+3K220534Wet Essential95 Personal LubricantTrigg Laboratories, Inc.20220—
+3K211998Desnuda ReflectGood Clean Love, Inc.20216—
+3K200527pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med…Pjur Group Luxembourg S.A.20210—
+3K200098VagiVital AktivgelPeptonic Medical AB20200—
+3K191052HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.P.A.20200—
+3K190323Aloe Glide LubricantDesert Harvest, Inc.20190—
+3K183050GLISSANT Intimate LubricantVjuvenate, LLC20190—
+3K182027Wet Organics Personal LubricantTrigg Laboratories Dba Wet International20182—
+3K162569YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal…Biotech Lubricants, Ltd.20172—
+3K162235Luvena Vaginal Moisturizer & LubricantLaclede, Inc.20170—
+3K161585Mano and Mano Personal LubricantMano and Mano Proprietary Limited20160—
+3K152628Pulse H20h!Toaster Labs, Inc.20161—
+3K152646Sylk Personal LubricantToro Management, LLC Dba Sylk20160—
+3K150094Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon VanillaGood Clean Love, Inc.20152—
+3K142790OneTouch Lubricant GelThai Nippon Rubber Industry Co., Ltd.20152—
+3K142726O Glide Personal LubricantGrafenberg Labs20155—
+3K140590Astroglide Sensual StrawberryBiofilm, Inc.20147—
+3K141034Azul Personal LubricantChurch & Dwight Co., Inc.20143—
+3K131084Sasmar Original, Sasmar ClassicSasmar, Inc.20130—
+3K051295I-D GlideWestridge Laboratories, Inc.200615—
+3K051288Vielle LubricantCst Medical Limited20060—
+4K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…Maxigen Biotech, Inc.20260—
+4K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC20260—
+4K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories20260—
+4K260068pjur NATURE Touch, 100 mlPjur Group Luxembourg S.A.20260—
+4K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.20260—
+4K242712LubriZenzsSk Zen, LLC20250—
+4K250629Sutil Rich Personal LubricantHathor Professional Skincare, Ltd.20250—
+4K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd.20251—
+4K220226X-Y Lubricating JellyR&R Medical Corporation, Ltd.20230—
+4K220273Onetouch Non-paraben Lubricant GelThai Nippon Rubber Industry Public Company Limited.20220—
+4K202017Passion Natural Water Based LubricantXr, LLC20210—
+4K191411Ah!Yes Ob Coco Personal LubricantBio-Tech Lubricants, Ltd.20201—
+4K182100Smile Makers Personal LubricantLfbeauty (Thailand) Limited20190—
+4K180764TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)Church & Dwight Co., Inc.20181—
+4K180219JO H2O Flavored Personal LubricantsUnited Consortium20180—
+4K171044Climax Personal LubricantWsm Investment, LLC, Dba Topco Sales20170—
+4K172447JO Gelato Flavored Personal LubricantsUnited Consortium20173—
+4K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc.20174—
+4K162207Restore Moisturizing Vaginal LubricantGood Clean Love20171—
+4K150153Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss…Package Solutions, LLC20151—
+4K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc.201512—
+5K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd.20260—
+5K251011Chiavaye Personal MoisturizerUnipack, LLC20250—
+5K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC20230—
+5K222175Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc..20222—
+5K221829Wet Flavored Personal LubricantsTrigg Laboratories, Inc.20220—
+5K202667Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc.20210—
+5K203654Solevy Co. LLC Water-Based Personal LubricantSolevy Co., LLC20211—
+5K192204Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva…Valencia Naturals, Inc.20190—
+5K190150Sage 2-in-1 Personal Lubricant and MoisturizerFairhaven Health, LLC20190—
+5K180014Creme de La Femme Feminine LubricantCewal, Inc. Dba Premiere Enterprises20180—
+5K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…United Consortium20180—
+5K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International20169—
+6K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)20260—
+6K232093Woo More Play Coconut Love OilWoo Essentials, Inc.20230—
+6K221137Play and Joy Water-Based LubricantInnovemed Bio-Tech Co., Ltd.20230—
+6K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…United Consortium20196—
+6K171021JO Agapé Personal LubricantUnited Consortium20171—
+7K200208Agape Warming Personal LubricantCC Wellness, LLC20205—
+7K183584JO H2O Jelly Original Personal LubricantUnited Consortium20190—
+8K243107Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.20250—
+8K212104Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd.20210—
+8K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for…CC Wellness, LLC20210—
+8K203257LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd.20201—
+9K210857Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd.20210—