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510(k) K201571

ACTIV.A.C. Negative Pressure Wound Therapy System by Kci USA, Inc. — Product Code OMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2020
Date Received
June 11, 2020
Clearance Type
Special
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

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.

Other clearances by Kci USA, Inc.

  • K241134 — 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) (May 23, 2024)
  • K200390 — V.A.C. DERMATAC Drape (May 18, 2020)
  • K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Manag (November 22, 2019)
  • DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units (April 19, 2019)
  • K181505 — V.A.C. DERMATAC Drape (March 28, 2019)
  • K183543 — ACTIV.A.C. Therapy Unit (March 20, 2019)
  • K181507 — PREVENA RESTOR(TM) Incision Management System (February 15, 2019)
  • K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management Sy (June 1, 2018)
  • K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management Sy (March 9, 2018)
  • K173447 — V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Neg (March 2, 2018)

Other clearances for product code OMP

  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa (November 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (October 3, 2025)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)
  • K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (June 27, 2025)
  • K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS G (February 18, 2025)
  • K233614 — Genadyne DUO NPWT (December 23, 2024)
  • K241061 — VERSA Negative Pressure Wound Therapy System (VCMPP-100) (August 21, 2024)
  • K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand) (August 19, 2024)
  • K241515 — NEXA™ NPWT System (July 26, 2024)