510(k) Report

FDA product code · Radiology

Radiation Therapy Marking Device

QRNClass II21 CFR 892.5785510(k) required2 decisions since 20210 recalls

2 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 255 days (half between 255 and 255). No recall names this code. The most-cited predicate is DEN200041, named by 1 later device.

A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses.

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, radiology panel

Twenty years of QRN 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 · QRN

1in 2023

2021: 12023: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRN

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

Recalls per year · QRN

No recall names QRN since 2007.

Adverse event reports per year · QRN

No MAUDE report names QRN since 2007.

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
20190—00
20200—00
20211—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — QRN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QRN? 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 QRN devices cite most?

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

  • DEN200041Comfort Marker 2.0.Medical Precision BV · 20211cites it

Which QRN devices have the deepest lineage?

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

  • K222112Comfort Marker 2.0Medical Precision BV · 20231generation

What has FDA decided in QRN lately?

  • K222112Comfort Marker 2.0Medical Precision BV · 2023
  • DEN200041Comfort Marker 2.0.Medical Precision BV · 2021

All 2 QRN decisions →