510(k) Report

FDA product code · General and plastic surgery

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

QFCClass II21 CFR 878.4783510(k) required3 decisions since 20190 recalls

3 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 235 days (half between 174 and 297). No recall names this code. The most-cited predicate is DEN180013, named by 2 later devices.

A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of QFC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QFC

1in 2023

2019: 12021: 12023: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QFC

Too few QFC 510(k)s in any year since 2007 to give a median.

Recalls per year · QFC

No recall names QFC since 2007.

Adverse event reports per year · QFC

1in 2024

2023: 12024: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code QFC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20211—00
20220—00
20231—01
20240—01
20250—00
20260—0—
FIG. 1 — QFC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QFC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do QFC devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy UnitsKci USA, Inc. · 20192cite it

Which QFC devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K223263Prevena Plus 125 Therapy Unit3M · 20239generations
  • K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy…Smith and Nephew Medical Limited · 20211generation

What has FDA decided in QFC lately?

  • K223263Prevena Plus 125 Therapy Unit3M · 20231 recall
  • K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy…Smith and Nephew Medical Limited · 2021
  • DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy UnitsKci USA, Inc. · 2019

All 3 QFC decisions →