# K172963: Master-Frank N95 Particulate Respirator

- Pathway: 510(k) (Traditional)
- Applicant: Master & Frank Enterprise Co., Ltd.
- Decided: Apr 4, 2018 after 190 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 K974068 (1997). 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)
- K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, San-M Package Co., Ltd. (2016) Summary page 5.

## Indications for use
The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K172963
Methodology: https://510kreport.com/methodology