# K201571: ACTIV.A.C. Negative Pressure Wound Therapy System

- Pathway: 510(k) (Special)
- Applicant: Kci USA, Inc.
- Decided: Jul 8, 2020 after 27 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: 5 generations back to K945062 (1995). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183543: ACTIV.A.C. Therapy Unit, Kci USA, Inc. (2019) Summary page 4.

## Most influential descendants
- K253199: Curasys 2 (EMDN0003) (2026), 0 descendants of its own
- K241134: 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) (2024), 0 descendants of its own
- K230233: Prospera Spectruum Negative Pressure Wound Therapy System (2024), 0 descendants of its own

## Indications for use
The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, it 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K201571
Methodology: https://510kreport.com/methodology