Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NUC — Predicate Candidate Screening
247 FDA 510(k) clearances under this product code; the 50 most recent screened below.
163 daysmedian FDA review time
308 days90th percentile
247clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 | 60 | 0 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | 2026-07-09 | 90 | 0 |
| K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026-07-06 | 28 | 0 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | 2026-06-22 | 189 | 0 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Pe | PR Personal Care Laboratories | 2026-06-11 | 52 | 0 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147 | Hathor Professional Skincare , Ltd. | 2026-06-09 | 270 | 0 |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026-05-21 | 132 | 0 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026-04-16 | 118 | 0 |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Ac | Hudi Pharma Srl | 2026-04-01 | 89 | 0 |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | 2026-03-06 | 84 | 0 |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | 2025-12-19 | 262 | 0 |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 | 91 | 0 |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | 2025-12-12 | 296 | 0 |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025-09-09 | 91 | 0 |
| K250142 | Water-based Lubricant | Global Protection Corp. | 2025-08-08 | 203 | 0 |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | 2025-08-08 | 228 | 0 |
| K242712 | LubriZenzs | Sk Zen, LLC | 2025-06-04 | 268 | 0 |
| K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. | 2025-05-09 | 221 | 0 |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. | 2025-05-02 | 60 | 0 |
| K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | 2025-03-20 | 176 | 0 |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011 | Hathor Professional Skincare , Ltd. | 2025-01-21 | 244 | 0 |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lub | Project Chemistry, Inc. | 2024-12-06 | 94 | 0 |
| K240745 | ID Free Personal Lubricant | Westridge Laboratories, Inc. | 2024-09-27 | 192 | 0 |
| K242162 | Coconut Hybrid | Good Clean Love, Inc. | 2024-09-19 | 57 | 0 |
| K240081 | Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. | 2024-08-16 | 218 | 0 |
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone P | Select Labs, LLC | 2024-06-07 | 164 | 0 |
| K232040 | Gynatrof | Tyros Biopharma, Inc. | 2024-03-01 | 235 | 0 |
| K231794 | Elegant™ Advanced CompHort | Viramal Limited | 2023-12-22 | 185 | 0 |
| K232093 | Woo More Play Coconut Love Oil | Woo Essentials, Inc. | 2023-12-01 | 141 | 0 |
| K232091 | JO Coconut Hybrid Cooling Personal Lubricant | CC Wellness, LLC | 2023-10-22 | 101 | 0 |
| K232090 | JO Coconut Hybrid Warming Personal Lubricant | CC Wellness, LLC | 2023-10-11 | 90 | 0 |
| K223519 | Carex Hybrid Personal Lubricant | Karex Industries Sdn. Bhd. | 2023-08-11 | 261 | 0 |
| K221137 | Play and Joy Water-Based Lubricant | Innovemed Bio-Tech Co., Ltd. | 2023-07-11 | 448 | 0 |
| K220646 | Play&Joy InvisiLube Lubricant Capsule | Innovemed Bio-Tech Co., Ltd. | 2023-07-10 | 493 | 0 |
| K230518 | HydraDose Vaginal Suppositories | MD Labs, LLC | 2023-06-23 | 116 | 0 |
| K230781 | Belle Sensilube | Rb Health (Us), LLC | 2023-06-20 | 90 | 0 |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Wate | CC Wellness, LLC | 2023-05-08 | 59 | 0 |
| K220226 | X-Y Lubricating Jelly | R&R Medical Corporation, Ltd. | 2023-03-28 | 425 | 0 |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & | Rb Health (Us), LLC | 2023-03-07 | 448 | 0 |
| K222567 | Playground For All Love Sesh | Playground For All | 2023-01-30 | 159 | 0 |
| K222175 | Bloomi Delight Oil-Based Personal Lubricant | The Bloomi Inc.. | 2022-11-15 | 117 | 0 |
| K220273 | Onetouch Non-paraben Lubricant Gel | Thai Nippon Rubber Industry Public Company Limited. | 2022-10-21 | 263 | 0 |
| K221243 | OFNat Lubricant (L15) | Suretex Limited | 2022-09-30 | 151 | 0 |
| K221829 | Wet Flavored Personal Lubricants | Trigg Laboratories, Inc. | 2022-09-23 | 92 | 0 |
| K221908 | JO CUMPLAY Personal Lubricant | CC Wellness, LLC | 2022-09-20 | 82 | 0 |
| K221328 | Bloomi Smooth Water Based Lubricant | The Bloomi Inc.. | 2022-08-04 | 90 | 0 |
| K220534 | Wet Essential95 Personal Lubricant | Trigg Laboratories, Inc. | 2022-07-07 | 133 | 0 |
| K221036 | Astroglide Warming | Biofilm, Inc. | 2022-07-01 | 85 | 0 |
| K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.R.L. | 2022-06-21 | 265 | 0 |
| K220355 | Astroglide Ultra Gentle Gel | Biofilm, Inc. | 2022-05-26 | 107 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda