# K222551: Humask Pro Vision, Humask Pro Vision 3000

- Pathway: 510(k) (Abbreviated)
- Applicant: Entreprise Premont, Inc.
- Decided: Nov 10, 2022 after 79 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
Longest line of descent: 1 generation back to K152561 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152561: Communicator Surgical Facemask with Clear Window, Prestige Ameritech, Ltd. (2016) Summary page 4.

## Indications for use
The Humask Pro Vision 3000 mask 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/K222551
Methodology: https://510kreport.com/methodology