# K123507: Kci NPWT Gauze Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Apr 4, 2013 after 142 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945062 (1995). 9 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys, Smith & Nephew, Inc. (2011) Summary page 1.

## Most influential descendants
- K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film (2017), 8 descendants of its own
- K172145: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (2018), 3 descendants of its own
- K182409: Applied Tissue Technologies PWD™ Platform Wound Dressing (2019), 2 descendants of its own
- K191460: PWD Platform Wound Dressing 3” x 5” Oblong (2019), 1 descendant of its own
- K254019: Wound Geni NPWT System (2026), 0 descendants of its own

## Indications for use
The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.0, lnfoV.A.C.0, V.AC. SimplicityTM, V.A.C.0 Freedom, V.AC. ATSO and V.A.C.Uta TM Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. The KCl NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.

Source page: https://510kreport.com/device/K123507
Methodology: https://510kreport.com/methodology