# K092580: Tidi Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Tidi Products,Llc
- Decided: Feb 23, 2010 after 186 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). 8 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 2.
- K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex, Crosstex Intl. (2002) Summary page 2.

## Most influential descendants
- K141875: Pasture 60S Surgical Mask (2015), 3 descendants of its own
- K093179: Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) (2010), 3 descendants of its own
- K152197: Skypro, SP01 Mask (2016), 2 descendants of its own
- K202139: Medical surgical mask (2020), 1 descendant of its own
- K213450: Medical surgical mask (Black mask, Level 1 and Level 3) (2022), 0 descendants of its own

## 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/K092580
Methodology: https://510kreport.com/methodology