# K143287: Fluidshield* Surgical Mask with Expanded Chamber

- Pathway: 510(k) (Abbreviated)
- Applicant: Halyard Health, Inc.
- Decided: Mar 24, 2015 after 127 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). 7 ancestors in all.
10 later devices descend from it; 4 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)
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model, Kimberly-Clark (2011) Summary page 5.

## Most influential descendants
- K201537: Protective Face Mask for Medical Use (2020), 4 descendants of its own
- K180874: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield (2018), 2 descendants of its own
- K212205: Medical Protective Masks (2021), 1 descendant of its own
- K210445: Nordiwell Surprotect Face Mask (2021), 1 descendant of its own
- K202107: Medical Protective Mask (2021), 1 descendant of its own

## Indications for use
The Expanded Chamber Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. 39123 Expanded Chamber Surgical Face Masks w/o Visor 39124 Expanded Chamber Surgical Face Mask with Visor

Source page: https://510kreport.com/device/K143287
Methodology: https://510kreport.com/methodology