# K100800: Tidi Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Tidi Products,Llc
- Decided: Jun 14, 2010 after 84 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: 6 generations back to K874608 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092580: Tidi Facemask, Tidi Products,Llc (2010) Summary page 2.
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 2.

## Indications for use
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K100800
Methodology: https://510kreport.com/methodology