ONLClass II

Conformal Brachytherapy Source

21 CFR 892.5730 / Radiology

ONL is the FDA product code for Conformal Brachytherapy Source, a class II device type, regulated under 21 CFR 892.5730. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2009-05-27, and no recalls.

Classification record

Product code: ONL
Device name: Conformal Brachytherapy Source
FDA definition: 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 other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device.
Regulation: 21 CFR 892.5730
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code ONL

By decision year

1 clearance under product code ONL with a decision year between 2009 and 2009, 2009 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ONL by decision year
Year	Clearances
2009	1

Applicants with the most clearances

Product code ONL

Applicants holding the most 510(k) clearances under product code ONL
Applicant	Clearances
Ri Consultants, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ONL.

Recent clearances

Product code ONL

K090321Class IIRic Conformal Source, Model 100Ri Consultants, LLC / cleared 2009-05-27

Recent recalls

Product code ONL

FDA records show no recalls under product code ONL.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)