# K964722: Delta N95 Respirator

- 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: 1 generation back to K955382 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Cited in the summary but kept off the family tree
- K967778: Isolair APR Type N95 Respirators. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Delta N95 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 / CDDC TB Prevention Guidelines.

Source page: https://510kreport.com/device/K964722
Methodology: https://510kreport.com/methodology