# DEN060009: 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator

- Pathway: De Novo (Post-NSE)
- Applicant: 3M Company
- Decided: May 8, 2007 after 217 days
- Product code: NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies)
- Device class: 2
- Regulation: 21 CFR 880.6260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K093189: Actiprotect UC N95 Respirator (2010), 0 descendants of its own

Source page: https://510kreport.com/device/DEN060009
Methodology: https://510kreport.com/methodology