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510(k) K254160

VacHeal Negative Pressure Wound Therapy System by VacHeal, LLC — Product Code OKO

K254160 is an FDA 510(k) premarket notification submitted by VacHeal, LLC for the device "VacHeal Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus), a Class II device regulated under 21 CFR 878.4683.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2026
Date Received
December 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Device Class
Class II
Regulation Number
878.4683
Review Panel
SU
Submission Type

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

Other clearances for product code OKO

  • K251156 — NPseal (May 15, 2025)
  • K250708 — NPseal (April 8, 2025)
  • K241522 — NPseal (20 and 25) (August 15, 2024)
  • K240244 — NPseal (Small, Medium, Large) (February 29, 2024)
  • K212971 — NPseal (February 10, 2022)
  • K211130 — NPseal (May 14, 2021)
  • K200305 — NPseal (May 26, 2020)
  • K193185 — Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (May 4, 2020)
  • K151710 — SNaP Wound Care System (November 19, 2015)
  • K142272 — SNaP Wound Care System (November 25, 2014)

FDA data resources