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510(k) K251888

VPAP Pediatric Face Mask by Hsiner Co., Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
June 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Hsiner Co., Ltd.

  • K102120 — NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MOD (August 12, 2011)
  • K091185 — 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER (July 24, 2009)
  • K082009 — HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS (August 22, 2008)
  • K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 (February 23, 2007)
  • K053466 — HSINER RESUSCITATOR (March 22, 2006)
  • K052811 — HSINER JET NEBULIZER, MODEL HS-31100 (December 21, 2005)

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