# K213427: PRIMED Pediatric Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Primed Medical Products, Inc.
- Decided: Nov 22, 2022 after 397 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: 8 generations back to K970835 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210321: Dukal Corporation Level 1 Pediatric Face Mask, Dukal Corporation (2022). Cleared while this submission was under review Summary page 4.
- K113340: Kimberly-Clark Child's Facemask, Kimberly-Clark (2012) Summary page 4.

## Indications for use
The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K213427
Methodology: https://510kreport.com/methodology