# K202831: The iMask Child's Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent, Inc.
- Decided: Aug 26, 2021 after 335 days
- Product code: OXZ (Pediatric/Child Facemask)
- 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
The iMask Child's Face Mask is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. This is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

Source page: https://510kreport.com/device/K202831
Methodology: https://510kreport.com/methodology