FDA product code NUC: Lubricant, Personal
NUC is the FDA product code for lubricant, personal. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 248 510(k) submissions under NUC, 55 in the last five years, from 138 different applicants. The average 510(k) review took 185 days (median 164); 160 days on average over the last three years. FDA has posted 7 recalls for NUC devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Lubricant, Personal |
| Device class | Class II |
| Regulation | 21 CFR 884.5300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NUC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 14 | 187 |
| 2018 | 15 | 150 |
| 2019 | 13 | 165 |
| 2020 | 19 | 192 |
| 2021 | 20 | 179 |
| 2022 | 14 | 139 |
| 2023 | 13 | 232 |
| 2024 | 6 | 160 |
| 2025 | 11 | 195 |
| 2026 | 11 | 125 |
Compare with all 510(k) review times · Search every NUC clearance
Top NUC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofilm, Inc. | 13 | 2022-07-01 |
| United Consortium | 13 | 2020-02-10 |
| CC Wellness, LLC | 10 | 2023-10-22 |
| Rb Health (Us), LLC | 8 | 2023-06-20 |
| Church & Dwight Co., Inc. | 8 | 2021-06-11 |
133 more applicants have NUC clearances. See the full list in Caduvo.
Most recent NUC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253989 | Maxigen Biotech, Inc. | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | 2026-09-03 | 265 |
| K261905 | Bumlicious, LLC (DBA Bumlicious) | BUM Oil | 2026-08-07 | 60 |
| K261177 | PINKSLIP, LLC | PINKSLIP Water-Based Personal Lubricant and Moisturizer | 2026-07-09 | 90 |
| K261909 | PCCA, Inc. | Plum Vagiceuticals Vaginal Moisturizing Suppositories | 2026-07-06 | 28 |
| K254011 | LBDO Group, Inc. | Flow Water-Based Personal Lubricant | 2026-06-22 | 189 |
Recalls for NUC devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-06-23.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code NUC?
NUC is the FDA product code for lubricant, personal. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is NUC?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUC?
Across 248 cleared submissions the average was 185 days from receipt to decision (median 164).
Which companies have the most NUC clearances?
Biofilm, Inc. (13); United Consortium (13); CC Wellness, LLC (10); Rb Health (Us), LLC (8); Church & Dwight Co., Inc. (8).
Have NUC devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2022-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code NUC
- Run a recall and safety report across every NUC manufacturer
- Watch product code NUC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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