# K052619: The Finger Guard

- Pathway: 510(k) (Traditional)
- Applicant: T F & G Products
- Decided: Jan 6, 2006 after 105 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
Longest line of descent: 1 generation back to K964821 (1997). 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)
- K964821: Coverox Sheath Models Number PS65, PS67, EPS65 and EPS67, Ventrex, Inc. (1997) Summary page 2.

## Indications for use
The Finger Guard® is intended for use as an accessory to a pulse oximeter reusable finger sensor / probe. When the clear Guard is placed on a digit and the sensor / probe placed over the Guard, it may provide a minimum barrier protection between the digit upon which it is placed and the probe. It can be used anywhere a pulse oximeter is needed. There is no other use for The Finger Guard®. If The Finger Guard® is used for any other purpose than stated above, it is used in that capacity without The Finger Guard® permission.

Source page: https://510kreport.com/device/K052619
Methodology: https://510kreport.com/methodology