# K212359: PWD Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Tissue Technologies, LLC
- Decided: Sep 21, 2022 after 419 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: 11 generations back to K945062 (1995). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172005: PICO 7 Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical Limited (2018) Summary page 4.
- K191460: PWD Platform Wound Dressing 3” x 5” Oblong, Applied Tissue Technologies, LLC (2019) Summary page 4.

## Indications for use
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions. PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

Source page: https://510kreport.com/device/K212359
Methodology: https://510kreport.com/methodology