Home / 510(k) Clearances / K100657

510(k) K100657

V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U by Kci USA, Inc. (Kinetic Concepts, Inc.) — Product Code OMP

K100657 is an FDA 510(k) premarket notification submitted by Kci USA, Inc. (Kinetic Concepts, Inc.) for the device "V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U". The FDA issued a decision of Substantially Equivalent on Sep 17, 2010. 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. (Kinetic Concepts, Inc.) has 12 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 17, 2010
Date Received
Mar 8, 2010
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.

Other clearances by Kci USA, Inc. (Kinetic Concepts, Inc.)

  • K162790 — V.A.C.ULTA Negative Pressure Wound Therapy System (Jan 26, 2017)
  • K161897 — PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE… (Oct 4, 2016)
  • K160451 — V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... (Jun 20, 2016)
  • K141017 — PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION… (Aug 20, 2015)
  • K133232 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION… (Mar 24, 2014)
  • K123878 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING (Jan 15, 2013)
  • K121883 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA… (Oct 11, 2012)
  • K120499 — ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM (Oct 5, 2012)
  • K103156 — V.A.C. VERAFLO CLEANSE DRESSING SYSTEM (Mar 14, 2011)
  • K102956 — V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING… (Dec 15, 2010)

Other clearances for product code OMP

  • K261338 — RENASYS DYNAFLOW Kit (66807741) (Sep 11, 2026)
  • K253263 — ConvaVAC™ Negative Pressure Wound Therapy System (Jun 24, 2026)
  • K253199 — CURASYS 2 (EMDN0003) (Jun 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 (Mar 12, 2026)
  • 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)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (Sep 11, 2025)

FDA data resources