# K152561: Communicator Surgical Facemask with Clear Window

- Pathway: 510(k) (Abbreviated)
- Applicant: Prestige Ameritech, Ltd.
- Decided: Jun 3, 2016 after 268 days
- Product code: FXX (Mask, 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K222551: Humask Pro Vision, Humask Pro Vision 3000 (2022), 0 descendants of its own

## Indications for use
The Communicator Surgical Facemask with Clear Window, FM86000, is single use disposable intended to be worn in the operating room as well as dental, isolation, and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K152561
Methodology: https://510kreport.com/methodology