# K202255: Skypro, SP02 Mask (3)

- Pathway: 510(k) (Traditional)
- Applicant: Skypro Medical Supplies Company
- Decided: Dec 24, 2021 after 501 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: 8 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)
- K152197: Skypro, SP01 Mask, Skypro Medical Supplies Company (2016) Summary page 4.

## Indications for use
“Skypro, SP02 Mask (Level 3)” is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.

Source page: https://510kreport.com/device/K202255
Methodology: https://510kreport.com/methodology