# K203265: nPro Surgical Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Np Medical, Inc.
- Decided: Feb 9, 2021 after 96 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.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142990: Insta-Gard Surgical and Procedure Face Mask, Cardinal Health200, LLC (2015) Summary page 4.

## Indications for use
The nPro surgical masks are intended for operating room personnel and other general health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and body fluids and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.

Source page: https://510kreport.com/device/K203265
Methodology: https://510kreport.com/methodology