K251902 is an FDA 510(k) clearance for the Vitaform Procedural Mask - Blue (Vitaform Blue). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Vitacore Industries, Inc. (Port Coquitlam, CA). The FDA issued a Cleared decision on September 17, 2025, 89 days after receiving the submission on June 20, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K251902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2025 |
| Decision Date | September 17, 2025 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |