# K955556: Fluid Resistant Mask

- Pathway: 510(k) (Traditional)
- Applicant: American Threshold Healthcare
- Decided: Apr 25, 1996 after 142 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: 1 generation back to K874608 (1987). 2 ancestors in all.
329 later devices descend from it; 2 cite it directly.
0 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874608: Tecnol Fluid Shield Surgical Mask, Tecnol New Jersey Wound Care, Inc. (1987) Summary page 1.
- K910110: Triple Layer Fluid-Resistant Molded Face Mask, 3M Company (1991) Summary page 1.

## Most influential descendants
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor (2008), 299 descendants of its own
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks (2011), 289 descendants of its own
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model (2011), 262 descendants of its own
- K131879: KC 300 Surgical Mask (2013), 185 descendants of its own
- K133070: SURGICAL FACE MASK (Ear Loops and Tie-on) (2015), 170 descendants of its own

## Indications for use
This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

Source page: https://510kreport.com/device/K955556
Methodology: https://510kreport.com/methodology