K202831 is an FDA 510(k) clearance for the The iMask Child's Face Mask. This device is classified as a Pediatric/child Facemask (Class II - Special Controls, product code OXZ).
Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on August 26, 2021, 335 days after receiving the submission on September 25, 2020.
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 | K202831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2020 |
| Decision Date | August 26, 2021 |
| Days to Decision | 335 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| 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. |