# K063013: Pleats Plus N95 Respirator, Models 1054 and 1054S

- Pathway: 510(k) (Abbreviated)
- Applicant: Aearo Company
- Decided: Dec 1, 2006 after 60 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pleats Plus 1050 N95 Respirators: named in the summary without a submission number

## Indications for use
The Pleats Plus™ 1054 and 1054S N95 Respirators and Surgical Masks 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/K063013
Methodology: https://510kreport.com/methodology