510(k) Report

Devices descending from K072647

40 later devices reach Glycerin & Paraben Free Astroglide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220355Astroglide Ultra Gentle GelBiofilm, Inc.20220—
+1K220653Astroglide Glycerin & Paraben FreeBiofilm, Inc.20222—
+1K213671Astroglide Sensual Strawberry Personal LubricantBiofilm, Inc.20220—
+1K141581Astroglide NaturalBiofilm, Inc.20147—
+1K130345Aqua Lube Natural Lubricant - Regular, WarmingMayer Laboratories, Inc.20136—
+1K094039Hyalo GynFidia Farmaceutici S.P.A.201019—
+2K240745ID Free Personal LubricantWestridge Laboratories, Inc.20241—
+2K200239Astroglide Organix GelBiofilm, Inc.20200—
+2K200114Astroglide Organix LiquidBiofilm, Inc.20203—
+2K193448BioNourish LubricantGood Clean Love, Inc.20200—
+2K181078The Sex GelNecessaire, Inc.20185—
+2K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.20164—
+2K160763ally Liquid Personal LubricantPrivate Label Production, LLC20160—
+2K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A.20159—
+2K143322Medline Natural Lubricating LiquidMedline Industries, Inc.20150—
+2K141718Internal Hydrating GelCombe Incorporated20142—
+3K254011Flow Water-Based Personal LubricantLBDO Group, Inc.20260—
+3K253983Water-based lubricantGuangzhou Haoyimai Trading Co., Ltd.20260—
+3K242645INA Moisturizing Intimate Lubricant Water-Based Personal LubricantProject Chemistry, Inc.20240—
+3K230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant…CC Wellness, LLC20230—
+3K221328Bloomi Smooth Water Based LubricantThe Bloomi Inc..20221—
+3K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L.20223—
+3K211998Desnuda ReflectGood Clean Love, Inc.20216—
+3K200731pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal…Pjur Group Luxembourg S.A.20212—
+3K200098VagiVital AktivgelPeptonic Medical AB20200—
+3K191052HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.P.A.20200—
+3K171855External Moisturizing GelCombe Incorporated20170—
+3K150615Vaginal Moisturizing GelCombe Incorporated20151—
+4K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC20260—
+4K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.20260—
+4K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories20260—
+4K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.20260—
+4K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…Hudi Pharma Srl20260—
+4K250629Sutil Rich Personal LubricantHathor Professional Skincare, Ltd.20250—
+4K242958Joylux Intimacy Gel (PG3100)Joylux, Inc.20250—
+4K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd.20251—
+4K240081Human LubricantJiangxi Wulinxiang Biological Technology Co., Ltd.20241—
+4K230518HydraDose Vaginal SuppositoriesMD Labs, LLC20230—
+5K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd.20260—
+5K251773Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel…Shenzhen Yongquan Medical Devices Co., Ltd.20250—