# K955382: 3M Model 1860 Health Care Particulate Respirator Type N95

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 1, 1996 after 159 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Model 1812 surgical mask: named in the summary without a submission number
- (no number) Tecnol DMR2010 respirator: named in the summary without a submission number
- (no number) Lazer™ Surgical Mask: named in the summary without a submission number

## Most influential descendants
- K964723: Racal N95 Resirator (1997), 0 descendants of its own
- K964722: Delta N95 Respirator (1997), 0 descendants of its own

## Indications for use
Meets the CDC guidelines for TB exposure control Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator) Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials Provides greater than 999 Racicrial Filtration Efficiency* to exhaied wearer generated microorganisims (*as determined by the modified Greene and Vesley test meihod)

Source page: https://510kreport.com/device/K955382
Methodology: https://510kreport.com/methodology