# K102923: Barrier N95 Particulate Respirator

- Pathway: 510(k) (Abbreviated)
- Applicant: Molnlycke Health Care
- Decided: Nov 19, 2010 after 49 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.
No later device cites it as a predicate yet.
0 of 3 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 1.

## Indications for use
The device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K102923
Methodology: https://510kreport.com/methodology