Cleared Traditional

VaporShield

K250847 · Vault Paragon Group, Inc. · General Hospital
Dec 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K250847 is an FDA 510(k) clearance for the VaporShield, 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 review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K250847 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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