510(k) · Cleared
ClearedOwl Universal RF System Urf-3AP (ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diros Technology, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Jan 22, 2010 as substantially equivalent to K062758 (Diros Technology, Inc., 2006) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jan 22, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020354 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020354 | Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230… | Baylis Medical Co., Inc. | 2002 | — |
| −1 | K062758 | Owl Urf-3AP | Diros Technology, Inc. | 2006 | — |
| 0 (this device) | K093185 | Owl Universal RF System Urf-3AP (ML) | Diros Technology, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062758 | Owl Urf-3APSummary page 2…NUMBER CODE OWL URF-3AP DIROS Class II/GXD K062758 TECHNOLOGY IN C_ _ _ _ _ _ _ _ _… | 2006 |
| * | K072478 | Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TDSummary page 2…C_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PMG- 115 BAYLIS Class II/GXD K072478 MEDICAL COMPANY __________… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DIROS QW™ URF-3AP(ML) LESION GENERATOR is intended for the following:
1 Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies,
pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain
The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093185: Owl Universal RF System Urf-3AP (ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093185
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026