# K251902: Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)

- Pathway: 510(k) (Traditional)
- Applicant: Vitacore Industries, Inc.
- Decided: Sep 17, 2025 after 89 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: 7 generations back to K874608 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220670: Magnum, Magnum Health and Safety Pvt, Ltd. (2022) Summary page 5.
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, 3M Healthcare (2019) Summary page 5.

## Indications for use
Vitaform Procedural Masks are intended to be worn to protect both the patient and the healthcare worker from transfer of microorganisms, body fluids, and particulate material. They are single-use and intended for use in infection control practices to reduce potential exposure to blood and body fluids.

Source page: https://510kreport.com/device/K251902
Methodology: https://510kreport.com/methodology