FDA product code ONL: Conformal Brachytherapy Source
ONL is the FDA product code for conformal brachytherapy source. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under ONL. The average 510(k) review took 107 days (median 107).
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.
Classification
| Field | Value |
|---|---|
| Device name | Conformal Brachytherapy Source |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ONL clearance
Top ONL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ri Consultants, LLC | 1 | 2009-05-27 |
Most recent ONL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090321 | Ri Consultants, LLC | RIC CONFORMAL SOURCE, MODEL 100 | 2009-05-27 | 107 |
Recalls for ONL devices
openFDA lists no recalls for product code ONL.
Frequently asked questions
What is FDA product code ONL?
ONL is the FDA product code for conformal brachytherapy source. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is ONL?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONL?
Across 1 cleared submissions the average was 107 days from receipt to decision (median 107).
Which companies have the most ONL clearances?
Ri Consultants, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONL
- Run a recall and safety report across every ONL manufacturer
- Watch product code ONL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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