# K152197: Skypro, SP01 Mask

- Pathway: 510(k) (Traditional)
- Applicant: Skypro Medical Supplies Company
- Decided: Aug 26, 2016 after 387 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). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141875: Pasture 60S Surgical Mask, Pasture Pharma Pte, Ltd. (2015) Summary page 5.

## Most influential descendants
- K202255: Skypro, SP02 Mask (3) (2021), 0 descendants of its own
- K203646: Disposable Medical Face Mask (2021), 0 descendants of its own

## Indications for use
The Skypro, SP01 Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non sterile.

Source page: https://510kreport.com/device/K152197
Methodology: https://510kreport.com/methodology