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510(k) K181507

PREVENA RESTOR(TM) Incision Management System by Kci USA, Inc. — Product Code OMP

K181507 is an FDA 510(k) premarket notification submitted by Kci USA, Inc. for the device "PREVENA RESTOR(TM) Incision Management System". The FDA issued a decision of Substantially Equivalent on February 15, 2019. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Kci USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2019
Date Received
June 7, 2018
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

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)
  • K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System (July 8, 2020)
  • 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)
  • 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

  • K253263 — ConvaVAC™ Negative Pressure Wound Therapy System (June 24, 2026)
  • K253199 — CURASYS 2 (EMDN0003) (June 23, 2026)
  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • K261291 — Nisus NPWT Canister 500-mL (CPC-500) (May 21, 2026)
  • K254019 — Wound Geni NPWT System (May 4, 2026)
  • 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)

FDA data resources