# HEB: Tampon, Menstrual, Unscented

- Device class: 2; regulation: 21 CFR 884.5470; FDA's rule: 510(k) required
- FDA decisions: 189
- 510(k) review time 2021–2025: median 85 days (middle half 30–160)
- Recalls: 35 (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: 2
- 2018: 5
- 2019: 7
- 2020: 2
- 2021: 6
- 2022: 3
- 2023: 5
- 2024: 2
- 2025: 6
- 2026: 1

## Most-cited predicates
- K122603: Ontex and Other Proprietary Names (2012), cited by 4
- K151170: Tosama 100% Organic Cotton Menstrual Tampon (2015), cited by 4
- K090819: Ontex Tampon (Unscented) (2009), cited by 3
- K061486: Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies) (2006), cited by 3
- K091084: Maxim Menstrual Tampons & Organyc Menstrual Tampons (2009), cited by 3
- K091749: U by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and Super Plus (2009), cited by 3
- K080775: Maxim Plastic Applicator & Non-Applicator Tampons (2008), cited by 3
- K051290: Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented) (2005), cited by 2
- K231341: Organic cotton tampon, Viscose tampon (2023), cited by 2
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (2021), cited by 2

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