# KMJ: Lubricant, Patient

- Device class: 1; regulation: 21 CFR 880.6375; FDA's rule: 510(k) exempt
- FDA decisions: 49
- Recalls: 14 (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)
- 2004: 1
- 2005: 1
- 2008: 3
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 3
- 2013: 1
- 2014: 1
- 2015: 1

## Most-cited predicates
- K935299: Astroglide (1994), cited by 12
- K810310: K-Y Lubricating Jelly (1981), cited by 6
- K092488: Dynarex Sterile Lubricating Jelly (2009), cited by 3
- K042563: Durex Play Warmer Lubricant (2005), cited by 3
- K871169: Lubricating Jelly (1987), cited by 2
- K041060: E-Z Lubricating Jelly (2004), cited by 2
- K944969: Steri-Lub Lubrication Gel (1995), cited by 2
- K974768: Pdi Sterile Lubricating Jelly (1998), cited by 2
- K951431: Aquagel Lubricating Jelly (1995), cited by 2
- K961222: Evron Gel (1996), cited by 1

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