# NUP: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

- Device class: 2; regulation: 21 CFR 880.5045; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 272 days (middle half 271–273)
- 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)
- 2005: 1
- 2006: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2017: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K042610: DR. Theiss Alergol Pollen Blocker Cream (2005), cited by 2
- K132520: Nasal Ease Allergy Blocker (2013), cited by 2
- K053625: Nasalguard (2006), cited by 2
- K170848: Alzair Allergy Blocker (2017), cited by 1
- K120894: Haymax (2012), cited by 1

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