# K210321: Dukal Corporation Level 1 Pediatric Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Dukal Corporation
- Decided: Mar 29, 2022 after 418 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
Longest line of descent: 7 generations back to K970835 (1997). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160100: Prestige Ameritech Pediatric/Child’s Face mask, Prestige Ameritech (2016) Summary page 4.

## Most influential descendants
- K213427: PRIMED Pediatric Facemask (2022), 0 descendants of its own

## Indications for use
The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.

Source page: https://510kreport.com/device/K210321
Methodology: https://510kreport.com/methodology