# K202824: BRS Procedure Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Blackbriar Regulatory Services, LLC
- Decided: Mar 25, 2021 after 182 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K211773: Single-use Surgical Mask (2021), 0 descendants of its own

## Indications for use
BRS Procedure Face Mask is a non-sterile, single use, disposable face mask intended to be worn to protect both healthcare personnel and patients from the transfer of microorganisms, blood and body fluids, and particulate material. This equipment is intended for the use in infection control practices to reduce the potential exposure to blood and fluids. BRS Level 1 Procedure Face Mask (Model# 00850021617004) BRS Level 2 Procedure Face Mask (Model# 00850021617196) BRS Level 3 Procedure Face Mask (Model# 00850021617561)

Source page: https://510kreport.com/device/K202824
Methodology: https://510kreport.com/methodology