# NZP: Sealant, Microbial

- Device class: 2; regulation: 21 CFR 878.4370; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 187 days (middle half 187–187)
- 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
- 2009: 1
- 2017: 1
- 2023: 1

## Most-cited predicates
- K083354: Floraseal, Model FS350D (2009), cited by 1
- K170505: SecurePortIV Catheter Securement Adhesive (2017), cited by 1

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