Cleared Traditional

PRIMED Pediatric Facemask

K213427 · Primed Medical Products, Inc. · General Hospital

Nov 2022

Decision

397d

Days

Class 2

Risk

About This 510(k) Submission

K213427 is an FDA 510(k) clearance for the PRIMED Pediatric Facemask, a Pediatric/child Facemask (Class II — Special Controls, product code OXZ), submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on November 22, 2022, 397 days after receiving the submission on October 21, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K213427 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2021
Decision Date	November 22, 2022
Days to Decision	397 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	OXZ — Pediatric/child Facemask
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4040
Definition	A Pediatric/child Facemask Is Intended To Be Worn By The Patient/child To Provide Protection For The Respiratory Tract. It Is A Single Use, Disposable Device That Is Provided Non-sterile. The Facemask Is Recommended For Use In A Healthcare Setting With Appropriate Adult Supervision.