# K220670: Magnum

- Pathway: 510(k) (Traditional)
- Applicant: Magnum Health and Safety Pvt, Ltd.
- Decided: Jun 28, 2022 after 113 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: 5 generations back to K874608 (1987). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212368: Surgical Face Mask, Anhui Tiankang Medical Technology Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K251902: Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (2025), 0 descendants of its own

## Indications for use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.

Source page: https://510kreport.com/device/K220670
Methodology: https://510kreport.com/methodology