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510(k) K250188

Wound Treatment System (VHT-200) by Vaporox, Inc. — Product Code KPJ

K250188 is an FDA 510(k) premarket notification submitted by Vaporox, Inc. for the device "Wound Treatment System (VHT-200)". The FDA issued a decision of Substantially Equivalent on March 10, 2025. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650. Vaporox, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2025
Date Received
January 22, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type

Other clearances by Vaporox, Inc.

  • K212121 — VHT-200 Wound Treatment System (March 23, 2023)

Other clearances for product code KPJ

  • K212121 — VHT-200 Wound Treatment System (March 23, 2023)
  • K190742 — EPIFLO-28 (December 13, 2019)
  • K112634 — NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (July 3, 2012)
  • K120764 — EPIFLO(R) (April 27, 2012)
  • K090681 — TANSCU O2 (August 12, 2009)
  • K080966 — HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (August 6, 2008)
  • K050156 — WHS-1000 WOUND HEALING SYSTEM (June 17, 2005)
  • K023456 — OXYBOX SYSTEM (February 24, 2003)
  • K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (December 17, 2002)
  • K020466 — HEC 1000 (May 8, 2002)

FDA data resources