Cleared Traditional

VPAP Pediatric Face Mask

K251888 · Hsiner Co., Ltd. · Anesthesiology
Mar 2026
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K251888 is an FDA 510(k) clearance for the VPAP Pediatric Face Mask, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Hsiner Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on March 12, 2026, 265 days after receiving the submission on June 20, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K251888 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2025
Decision Date March 12, 2026
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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