Atlas FDA

NUC

247 FDA 510(k) clearances · Product code

163 daysmedian time to decision
308 days90th percentile
247clearances measured

FDA profile

Official device name
Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
FDA definition
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.
Adverse events (MAUDE)
2009: 13 · 2012: 6 · 2014: 14 · 2015: 8 · 2016: 14 · 2017: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BUM Oil (K261905)Bumlicious, LLC (DBA “Bumlicious”)2026-08-07
PINKSLIP Water-Based Personal Lubricant and Moisturizer (K261177)PINKSLIP, LLC2026-07-09
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (K261909)PCCA, Inc.2026-07-06
Flow Water-Based Personal Lubricant (K254011)LBDO Group, Inc.2026-06-22
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (K261292)PR Personal Care Laboratories2026-06-11
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (K252914)Hathor Professional Skincare , Ltd.2026-06-09
pjur NATURE Touch, 100 ml (K260068)Pjur Group Luxembourg S.A.2026-05-21
Julva Velvé Water-Based Personal Lubricant (K254101)Golden Isles Medical, Inc.2026-04-16
Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (K260007)Hudi Pharma Srl2026-04-01
Water-based lubricant (K253983)Guangzhou Haoyimai Trading Co., Ltd.2026-03-06
Chiavaye Personal Moisturizer (K251011)Unipack, LLC2025-12-19
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) (K252935)Foshan Pingchuang Medical Technology Co., Ltd.2025-12-15
Cerynë Intimate Care (K250488)Ansella Therapeutics2025-12-12
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) (K251773)Shenzhen Yongquan Medical Devices Co., Ltd.2025-09-09
Water-based Lubricant (K250142)Global Protection Corp.2025-08-08
Plain Water-based Lubricant (K243972)Global Protection Corp.2025-08-08
LubriZenzs (K242712)Sk Zen, LLC2025-06-04
Water Solubility Human Body Lubricant (K243107)Dongguan Yanxuan Biotechnology Co., Ltd.2025-05-09
Sutil Rich Personal Lubricant (K250629)Hathor Professional Skincare , Ltd.2025-05-02
Joylux Intimacy Gel (PG3100) (K242958)Joylux, Inc.2025-03-20
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (K241443)Hathor Professional Skincare , Ltd.2025-01-21
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant (K242645)Project Chemistry, Inc.2024-12-06
ID Free Personal Lubricant (K240745)Westridge Laboratories, Inc.2024-09-27
Coconut Hybrid (K242162)Good Clean Love, Inc.2024-09-19
Human Lubricant (K240081)Jiangxi Wulinxiang Biological Technology Co., Ltd.2024-08-16
Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant (K234099)Select Labs, LLC2024-06-07
Gynatrof (K232040)Tyros Biopharma, Inc.2024-03-01
Elegant™ Advanced CompHort (K231794)Viramal Limited2023-12-22
Woo More Play Coconut Love Oil (K232093)Woo Essentials, Inc.2023-12-01
JO Coconut Hybrid Cooling Personal Lubricant (K232091)CC Wellness, LLC2023-10-22
JO Coconut Hybrid Warming Personal Lubricant (K232090)CC Wellness, LLC2023-10-11
Carex Hybrid Personal Lubricant (K223519)Karex Industries Sdn. Bhd.2023-08-11
Play and Joy Water-Based Lubricant (K221137)Innovemed Bio-Tech Co., Ltd.2023-07-11
Play&Joy InvisiLube Lubricant Capsule (K220646)Innovemed Bio-Tech Co., Ltd.2023-07-10
HydraDose Vaginal Suppositories (K230518)MD Labs, LLC2023-06-23
Belle Sensilube (K230781)Rb Health (Us), LLC2023-06-20
JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 (K230674)CC Wellness, LLC2023-05-08
X-Y Lubricating Jelly (K220226)R&R Medical Corporation, Ltd.2023-03-28
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (K213892)Rb Health (Us), LLC2023-03-07
Playground For All Love Sesh (K222567)Playground For All2023-01-30
Bloomi Delight Oil-Based Personal Lubricant (K222175)The Bloomi Inc..2022-11-15
Onetouch Non-paraben Lubricant Gel (K220273)Thai Nippon Rubber Industry Public Company Limited.2022-10-21
OFNat Lubricant (L15) (K221243)Suretex Limited2022-09-30
Wet Flavored Personal Lubricants (K221829)Trigg Laboratories, Inc.2022-09-23
JO CUMPLAY Personal Lubricant (K221908)CC Wellness, LLC2022-09-20
Bloomi Smooth Water Based Lubricant (K221328)The Bloomi Inc..2022-08-04
Wet Essential95 Personal Lubricant (K220534)Trigg Laboratories, Inc.2022-07-07
Astroglide Warming (K221036)Biofilm, Inc.2022-07-01
Revaree Plus Vaginal Suppositories (K213220)Farma-Derma S.R.L.2022-06-21
Astroglide Ultra Gentle Gel (K220355)Biofilm, Inc.2022-05-26
Astroglide Glycerin & Paraben Free (K220653)Biofilm, Inc.2022-05-06
Sensuva Premium Silicone Personal Lubricant (K212260)Valencia Naturals, Inc.2022-04-13
Astroglide Sensual Strawberry Personal Lubricant (K213671)Biofilm, Inc.2022-03-03
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry (K213400)Rb Health (Us)2022-03-01
Playboy Premium Silicone Lubricant (K210095)Thai Nippon Rubber Industry Public Company Limited.2021-11-23
Desnuda Reflect (K211998)Good Clean Love, Inc.2021-11-18
Medley (K212000)Good Clean Love, Inc.2021-11-18
Water-soluble Personal Lubricant (K212104)Foshan Pingchuang Medical Technology Co., Ltd.2021-11-18
Sensual Massage, Ultra Pure (K211967)Dreambrands, Inc.2021-11-09
Personal Lubricant (K210857)Shenzhen Huanqiu Xuebao Technology Co., Ltd.2021-09-24
Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 (K201612)Viramal Limited2021-09-02
Grosz Play Feel (K211088)Rb Health (Us), LLC2021-07-09
Coconu Water Based Personal Lubricant (K210814)Coconu, LLC2021-06-14
Replens Long-Lasting Vaginal Moisturizer (K203818)Church & Dwight Co., Inc.2021-06-11
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit (K210986)CC Wellness, LLC2021-06-10
H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two (K210972)CC Wellness, LLC2021-06-10
Personal Lubricant Jelly (K202667)Nantong Health & Beyond Hygienic Products, Inc.2021-05-18
Astroglide X Silicone Personal Lubricant (K210242)Biofilm, Inc.2021-04-28
Solevy Co. LLC Silicone Based Personal Lubricant (K203644)Solevy Co., LLC2021-04-19
Solevy Co. LLC Water-Based Personal Lubricant (K203654)Solevy Co., LLC2021-04-19
pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur (K200527)Pjur Group Luxembourg S.A.2021-02-19
pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 (K200731)Pjur Group Luxembourg S.A.2021-01-21
Trophikos Vaginal Moisturizer (K201922)Trophikos, LLC2021-01-14
Passion Natural Water Based Lubricant (K202017)Xr, LLC2021-01-08
LUBi Water Based Personal Lubricant (K203257)Boya Biotechnology Co., Ltd.2020-12-23
pjur WOMAN Nude pjur med SENSITIVE glide (K200730)Pjur Group Luxembourg S.A.2020-12-17
Vagisan MoistCream Cremolum (K193444)Dr. August Wolff GmbH & Co. KG Arzneimittel2020-12-04
Astroglide Organix Gel (K200239)Biofilm, Inc.2020-11-13
VagiVital Aktivgel (K200098)Peptonic Medical AB2020-11-10
Astroglide Organix Liquid (K200114)Biofilm, Inc.2020-10-13
KY Grosz Jelly (K201186)Rb Health (Us), LLC2020-07-30
Agape Cooling Personal Lubricant (K200894)CC Wellness, LLC2020-07-02
Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant (K200602)CC Wellness, LLC2020-06-03
Bunny Wax Personal Lubricant (K192779)Reoxcyn, LLC2020-06-02
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming (K200457)CC Wellness, LLC2020-05-22
Agape Warming Personal Lubricant (K200208)CC Wellness, LLC2020-04-27
KY Grosz Liquid (K193032)Rb Health (Us), LLC2020-04-20
KY Grosz UltraGel (K192982)Rb Health (Us), LLC2020-04-14
SILICONE Personal Lubricant (K191654)Bath Concept Cosmetics (Dongguan) Co., Ltd.2020-04-14
BioNourish Lubricant (K193448)Good Clean Love, Inc.2020-03-12
JO for Him H2O Gel Original Personal Lubricant (K192203)United Consortium2020-02-10
Ah!Yes Ob Coco Personal Lubricant (K191411)Bio-Tech Lubricants, Ltd.2020-02-06
HyaloGYN Vaginal Moisturizing Suppositories (K191052)Fidia Farmaceutici S.P.A.2020-01-09
Satisfaite (K190752)Femmepharma Consumer Healthcare, LLC2019-12-13
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, (K192204)Valencia Naturals, Inc.2019-11-19
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) (K191480)Trigg Laboratories, Inc. D/B/A Wet International2019-10-11
Aloe Glide Lubricant (K190323)Desert Harvest, Inc.2019-09-25
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant (K190858)United Consortium2019-09-18
JO Premium Jelly Original Personal Lubricant (K191214)United Consortium2019-08-01
Sage 2-in-1 Personal Lubricant and Moisturizer (K190150)Fairhaven Health, LLC2019-07-16
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Every clearance here is in the API, with alerts when new ones post.