# K242502: Aurelia Surgical Mask ASTM Level-3 (2130)

- Pathway: 510(k) (Traditional)
- Applicant: Supermax Healthcare Canada – Supermax Medical
- Decided: Nov 12, 2024 after 82 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor, Crosstex International (2008) Summary page 5.

## Indications for use
Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile

Source page: https://510kreport.com/device/K242502
Methodology: https://510kreport.com/methodology