# K214094: ROKI Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Roki Co., Ltd.
- Decided: Feb 24, 2022 after 58 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201924: Single-Use Surgical Mask, Qiqihar Hengxin Medical Supplies, Ltd. (2021) Summary page 4.

## Indications for use
The ROKI Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The ROKI Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. Model: L and M, white color, and Level 3 barrier level per ASTM F2100-19.

Source page: https://510kreport.com/device/K214094
Methodology: https://510kreport.com/methodology