# K955835: Fluid Barrier Boot Knee & Ankle-High

- Pathway: 510(k) (Traditional)
- Applicant: Instrument Makar, Inc.
- Decided: Nov 19, 1996 after 329 days
- Product code: FXP (Cover, Shoe, Operating-Room)
- Device class: 1
- 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 K914702 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914702: Sterile View (TM) Knee-High Boots/Depuy Shoe Boots, Depuy, Inc. (1993) Summary page 2.

## Indications for use
The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.

Source page: https://510kreport.com/device/K955835
Methodology: https://510kreport.com/methodology