# K964723: Racal N95 Resirator

- Pathway: 510(k) (Traditional)
- Applicant: Racal Filter Technologies, Inc.
- Decided: Feb 7, 1997 after 74 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
Longest line of descent: 2 generations back to K922507 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955382: 3M Model 1860 Health Care Particulate Respirator Type N95, 3M Company (1996) Summary page 2.
- K960778: Isolair Apr Type N95, Louis M. Gerson Co., Inc. (1996) Summary page 2.

## Indications for use
The Racal N93 Respirator and Surgical Mask will be used for the protection of the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CDC TB Prevention Guidelines.

Source page: https://510kreport.com/device/K964723
Methodology: https://510kreport.com/methodology