# K972849: Isosafe Earloop Procedure Mask (Blue, Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Cypress Medical Products, Ltd.
- Decided: May 28, 1998 after 300 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
An Earloop Procedure Mask is a disposable device intended for medical purposes that is worn over the examiner’s mouth and nose to prevent contamination between examiner and patient.

Source page: https://510kreport.com/device/K972849
Methodology: https://510kreport.com/methodology