# K964821: Coverox Sheath Models Number PS65, PS67, EPS65 and EPS67

- Pathway: 510(k) (Traditional)
- Applicant: Ventrex, Inc.
- Decided: Jul 16, 1997 after 226 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052619: The Finger Guard (2006), 0 descendants of its own

## Indications for use
The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the “clothes pin” style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination. The COVERox Sheath is supplied non-sterile and is intended for single use only.

Source page: https://510kreport.com/device/K964821
Methodology: https://510kreport.com/methodology