# K072067: N95 Surgical Respirator, Type AP0018 and AP0028

- Pathway: 510(k) (Traditional)
- Applicant: Shuenn Bao Shing Corporation
- Decided: Jan 8, 2008 after 165 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)
- K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S, Aearo Co. (2004) Summary page 1.

## Indications for use
The N95 Surgical Respirator AP0018 and AP0028 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.

Source page: https://510kreport.com/device/K072067
Methodology: https://510kreport.com/methodology