# HIL: Tampon, Menstrual, Scented, Scented-Deodorized

- Device class: 2; regulation: 21 CFR 884.5460; FDA's rule: 510(k) required
- FDA decisions: 84
- 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)
- 2002: 4
- 2003: 2
- 2004: 2
- 2005: 2
- 2006: 1
- 2007: 2
- 2008: 2
- 2012: 2
- 2013: 1
- 2014: 1

## Most-cited predicates
- K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons (2007), cited by 4
- K011996: Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus (2001), cited by 4
- K081555: Tampax Pearl Plastic Applicator Tampons, Scented and Unscented (2008), cited by 3
- K830966: Playtex Tampons (1983), cited by 3
- K961870: Playtex Slimfit Tampons (1996), cited by 2
- K912002: Playtex Non-Deodorant/Deodorant Tampons (1991), cited by 2
- K032173: Femtex and Private Label Scented Plastic Applicator Tampons (2003), cited by 2
- K042773: Rostam Scented and Unscented Plastic Applicator Tampons (2004), cited by 2
- K040312: Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus (2004), cited by 2
- K020201: Playtex Deodorant Tampons, Model 34902 (2002), cited by 2

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