# K070168: N95 Respirator, Models N9504C, N9504CS and N9514C

- Pathway: 510(k) (Abbreviated)
- Applicant: Aearo Company
- Decided: Apr 18, 2007 after 90 days
- Product code: MSH (Respirator, 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). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960778: Isolair Apr Type N95, Louis M. Gerson Co., Inc. (1996) Summary page 2.

## Most influential descendants
- K072359: Aearo Company Surgical N95 Respirators, Models N9508C and N9511C (2007), 0 descendants of its own

## Indications for use
Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Source page: https://510kreport.com/device/K070168
Methodology: https://510kreport.com/methodology