K213427 is an FDA 510(k) clearance for the PRIMED Pediatric Facemask. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4040. 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..
| 510(k) Number | K213427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |