# K040333: Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops

- Pathway: 510(k) (Traditional)
- Applicant: Valumax Intl., Inc.
- Decided: Jun 7, 2004 after 117 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: 3 generations back to K874608 (1987). 5 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex, Crosstex Intl. (2002) Summary page 2.

## Most influential descendants
- K051291: Non-Sterile Surgical Mask (2005), 20 descendants of its own
- K092580: Tidi Facemask (2010), 9 descendants of its own
- K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560 (2006), 6 descendants of its own
- K111559: Surgical Masks (2011), 4 descendants of its own
- K201137: Asept Surgical Face Mask (2020), 3 descendants of its own

## Indications for use
ValuMaxE Surgical Masks 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 materials.

Source page: https://510kreport.com/device/K040333
Methodology: https://510kreport.com/methodology