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510(k) K162159

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing by Vr Medical Technologies, LLC — Product Code OMP

K162159 is an FDA 510(k) premarket notification submitted by Vr Medical Technologies, LLC for the device "VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing". The FDA issued a decision of Substantially Equivalent on Apr 28, 2017. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 28, 2017
Date Received
Aug 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type
510(k)

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. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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  • K254019 — Wound Geni NPWT System (May 4, 2026)
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  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White… (Nov 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (Oct 3, 2025)
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FDA data resources