# NUC: Lubricant, Personal

- Device class: 2; regulation: 21 CFR 884.5300; FDA's rule: 510(k) required
- FDA decisions: 249
- 510(k) review time 2021–2025: median 147 days (middle half 92–245)
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 14
- 2018: 15
- 2019: 13
- 2020: 19
- 2021: 20
- 2022: 14
- 2023: 13
- 2024: 6
- 2025: 11
- 2026: 12

## Most-cited predicates
- K021492: K-Y Brand Warming Liquid Personal Lubricant (2002), cited by 9
- K124044: Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants (2013), cited by 9
- K072647: Glycerin & Paraben Free Astroglide (2008), cited by 6
- K183302: KY Banksy Aloe (2019), cited by 5
- K180712: Coconut Infused Hybrid Personal Lubricant (2018), cited by 5
- K211998: Desnuda Reflect (2021), cited by 5
- K062796: K-Y Brand Intrigue (2006), cited by 5
- K020827: K-Y Brand Ultra Gel Personal Lubricant (2002), cited by 5
- K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035 (2010), cited by 5
- K110690: One Personal Lubricant (Silicone) (2012), cited by 5

Source page: https://510kreport.com/product-code/NUC
Data by year (CSV): https://510kreport.com/product-code/NUC.csv