NUCClass II

Lubricant, Personal

21 CFR 884.5300 / Obstetrics/Gynecology

NUC is the FDA product code for Lubricant, Personal, a class II device type, regulated under 21 CFR 884.5300. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 247 510(k) clearances under this code, the most recent dated 2026-08-07, and 7 recalls.

Classification record

Product code: NUC
Device name: Lubricant, Personal
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.
Regulation: 21 CFR 884.5300
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 249
Ingested recalls: 7

Clearances, product code NUC

By decision year

249 clearances under product code NUC with a decision year between 2000 and 2026, 2015 the highest year at 21.

Show the numbers

510(k) clearances under FDA product code NUC by decision year
Year	Clearances
2000	1
2001	4
2002	5
2004	4
2005	7
2006	8
2007	5
2008	7
2009	2
2010	4
2011	2
2012	6
2013	11
2014	11
2015	21
2016	14
2017	14
2018	15
2019	13
2020	19
2021	20
2022	14
2023	13
2024	6
2025	11
2026	12

Applicants with the most clearances

Product code NUC

Applicants holding the most 510(k) clearances under product code NUC
Applicant	Clearances
United Consortium	14
Biofilm, Inc.	13
CC Wellness LLC	10
Rb Health (Us), LLC	9
Church & Dwight Co., Inc.	8
Good Clean Love, Inc.	7
pjur group Luxembourg S.A.	7
Reckitt Benckiser LLC	6
Mcneil-Ppc, Inc.	5
Ssl Americas, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 124 companies shown, in name order