# PEB: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

- Device class: 2; regulation: 21 CFR 884.5300; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 161 days (middle half 157–164)
- Recalls: 0 (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)
- 2006: 1
- 2008: 1
- 2013: 1
- 2015: 1
- 2017: 1
- 2019: 2
- 2020: 1
- 2022: 2

## Most-cited predicates
- K072741: Pre-VA Vaginal Lubricant (2008), cited by 4
- K182585: JO Actively Trying Personal Lubricant (2019), cited by 2
- K051436: Pre' Vaginal Lubricant (2006), cited by 1
- K162319: BabyDance Fertility Lubricant (2017), cited by 1
- K141132: Astroglide TTC Fertility Friendly Personal Lubricant (2015), cited by 1

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