# K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S

- Pathway: 510(k) (Abbreviated)
- Applicant: Aearo Co.
- Decided: Nov 10, 2004 after 124 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.
15 later devices descend from it; 5 cite it directly.
0 of 18 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
- K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks (2005), 11 descendants of its own
- K070139: Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 (2007), 5 descendants of its own
- K070782: Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F (2007), 3 descendants of its own
- K061859: Inovel Health Care N95 Particulate Respirators & Surgical Masks (2006), 3 descendants of its own
- K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold (2009), 2 descendants of its own

## Indications for use
The Pleats PlusTM 1050 and 1050S 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/K041855
Methodology: https://510kreport.com/methodology