# K022256: Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green

- Pathway: 510(k) (Traditional)
- Applicant: Tucker & Associates
- Decided: Apr 26, 2004 after 654 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 K970835 (1997). 1 ancestor in all.
77 later devices descend from it; 6 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970835: Face Mask, Surgical Mask, Non-Sterile, Tucker & Associates (1997) Summary page 1.

## Most influential descendants
- K060776: Surgical Face Mask (2006), 73 descendants of its own
- K061716: Prestige Ameritech Face Mask (2006), 61 descendants of its own
- K122717: Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask (2012), 45 descendants of its own
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) (2018), 35 descendants of its own
- K201479: DemeMASK (2020), 17 descendants of its own

## Indications for use
This device is intended to be worn to protect both the patient and healthcare personnel From transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K022256
Methodology: https://510kreport.com/methodology