FDA product code · General and plastic surgery

Wound Autofluorescence Imaging Device

Name: FDA decisions, review times, recalls and adverse event reports for product code QCR
Creator: 510(k) Report

QCRClass I21 CFR 878.4165510(k) exempt1 decision0 recalls

FDA lists QCR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision. No recall names this code. The most-cited predicate is DEN180008, named by 1 later device.

A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

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 QCR 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.

FIG. 1 — QCR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QCR? 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

Wound Autofluorescence Imaging Device

Which predicates do QCR devices cite most?