FDA Product Code NUC: Lubricant, Personal
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.
Leading manufacturers include Biofilm, Inc., United Consortium and CC Wellness, LLC.
247
Total
247
Cleared
185d
Avg days
2000
Since
Stable submission activity - 23 submissions in the last 2 years
Review times improving: avg
154d
recently vs 188d historically
FDA 510(k) Cleared Lubricant, Personal Devices (Product Code NUC)
247 devices
Cleared
Aug 07, 2026
BUM Oil
Bumlicious, LLC (DBA “Bumlicious”)
Obstetrics & Gynecology
60d
Cleared
Jul 09, 2026
PINKSLIP Water-Based Personal Lubricant and Moisturizer
PINKSLIP, LLC
Obstetrics & Gynecology
90d
Cleared
Jul 06, 2026
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories
Pcca, Inc.
Obstetrics & Gynecology
28d
Cleared
Jun 22, 2026
Flow Water-Based Personal Lubricant
LBDO Group, Inc.
Obstetrics & Gynecology
189d
Cleared
Jun 11, 2026
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
PR Personal Care Laboratories
Obstetrics & Gynecology
52d
Cleared
Jun 09, 2026
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology
270d
Cleared
May 21, 2026
pjur NATURE Touch, 100 ml
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology
132d
Cleared
Apr 16, 2026
Julva Velvé Water-Based Personal Lubricant
Golden Isles Medical, Inc.
Obstetrics & Gynecology
118d
Cleared
Apr 01, 2026
Hyaluronic Acid Vaginal Suppository (HA 5 mg)
Hudi Pharma Srl
Obstetrics & Gynecology
89d
Cleared
Mar 06, 2026
Water-based lubricant
Guangzhou Haoyimai Trading Co., Ltd.
Obstetrics & Gynecology
84d
Cleared
Dec 19, 2025
Chiavaye Personal Moisturizer
Unipack, LLC
Obstetrics & Gynecology
262d
Cleared
Dec 15, 2025
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
Foshan Pingchuang Medical Technology Co., Ltd.
Obstetrics & Gynecology
91d
Cleared
Dec 12, 2025
Cerynë Intimate Care
Ansella Therapeutics
Obstetrics & Gynecology
296d
Cleared
Sep 09, 2025
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant
Shenzhen Yongquan Medical Devices Co., Ltd.
Obstetrics & Gynecology
91d
Cleared
Aug 08, 2025
Plain Water-based Lubricant
Global Protection Corp.
Obstetrics & Gynecology
228d
Cleared
Aug 08, 2025
Water-based Lubricant
Global Protection Corp.
Obstetrics & Gynecology
203d
Cleared
Jun 04, 2025
LubriZenzs
Sk Zen, LLC
Obstetrics & Gynecology
268d
Cleared
May 09, 2025
Water Solubility Human Body Lubricant
Dongguan Yanxuan Biotechnology Co., Ltd.
Obstetrics & Gynecology
221d
Cleared
May 02, 2025
Sutil Rich Personal Lubricant
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology
60d
Cleared
Mar 20, 2025
Joylux Intimacy Gel (PG3100)
Joylux, Inc.
Obstetrics & Gynecology
176d
Cleared
Jan 21, 2025
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011)
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology
244d
Cleared
Dec 06, 2024
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
Project Chemistry, Inc.
Obstetrics & Gynecology
94d
Cleared
Sep 27, 2024
ID Free Personal Lubricant
Westridge Laboratories, Inc.
Obstetrics & Gynecology
192d
Cleared
Sep 19, 2024
Coconut Hybrid
Good Clean Love, Inc.
Obstetrics & Gynecology
57d
About Product Code NUC - Regulatory Context
510(k) Submission Activity
247 total 510(k) submissions under product code NUC since 2000, with 247 receiving FDA clearance (average review time: 185 days).
Submission volume has remained relatively stable over the observed period, with 23 submissions in the last 24 months.
FDA 510(k) Review Time - NUC Product Code
Recent submissions under NUC have taken an average of 154 days to reach a decision - down from 188 days historically, suggesting improved FDA processing for this classification.
NUC devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →