510(k) Report

FDA product code · Radiology

Conformal Brachytherapy Source

ONLClass II21 CFR 892.5730510(k) required1 decision since 20090 recalls

1 FDA decision since 2009. No recall names this code. The most-cited predicate is K090321, named by 2 later devices.

The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. This brachytherapy source may be used concurrently with or following treatment with…

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 ONL 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 · ONL

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ONL

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

Recalls per year · ONL

No recall names ONL since 2007.

Adverse event reports per year · ONL

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code ONL, 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
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — ONL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ONL? 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 ONL devices cite most?

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

  • K090321Ric Conformal Source, Model 100Ri Consultants, LLC · 20092cite it

Which ONL devices have the deepest lineage?

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

  • K090321Ric Conformal Source, Model 100Ri Consultants, LLC · 20091generation

What has FDA decided in ONL lately?

  • K090321Ric Conformal Source, Model 100Ri Consultants, LLC · 2009

The one ONL decision →

Related product codes

Other codes under 21 CFR 892.5730.

KXK Source, Brachytherapy, RadionuclideIWG Seed, Isotope, Gold, Titanium, PlatinumNMP Needle, Isotope, ReprocessedOIN Prostate Seeding KitIWI Source, Isotope, Sealed, Gold, Titanium…IWF Needle, Isotope, Gold, Titanium, PlatinumIWA Source, Wire, Iridium, Radioactive