# K072359: Aearo Company Surgical N95 Respirators, Models N9508C and N9511C

- Pathway: 510(k) (Abbreviated)
- Applicant: Aearo Company
- Decided: Nov 8, 2007 after 78 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: 3 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)
- K070168: N95 Respirator, Models N9504C, N9504CS and N9514C, Aearo Company (2007) Summary page 2.

## Indications for use
Aearo Surgical N95 Respirators, N9508C and N9511 are NIOSH approved N95 respirators 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/K072359
Methodology: https://510kreport.com/methodology