K250847 is an FDA 510(k) clearance for the VaporShield. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Vault Paragon Group, Inc. (Garden City, US). The FDA issued a Cleared decision on December 12, 2025, 267 days after receiving the submission on March 20, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K250847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |