510(k) Report

510(k) · Cleared

Cleared

Owl Radiofrequency System, Model Urf-2AP

K021869510(k) SpecialCleared Jul 1, 200225-day reviewClass II21 CFR 882.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diros Technology, Inc. · GXD Generator, Lesion, Radiofrequency

Cleared on Jul 1, 2002 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.

Decided
Jul 1, 2002
Review
25 days
Class
Class II
Product code
GXD
Recalls
None
Predicates
0

23 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 3 descendants cleared2008: 3 descendants cleared2025: 2 descendants cleared2019: 2 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2023: 2 descendants cleared2015: 1 descendant cleared2020: 2 descendants cleared2024: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK021869 Owl Radiofrequency System, Model Urf-2APDiros Technology, Inc. · 2002
  2. Descendant · cites it directly · 20 of its ownK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  4. Descendant · 2 generations on · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  5. Descendant · 2 generations on · 7 of its ownK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  6. Descendant · 3 generations on · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32008: 32010: 12011: 22013: 12014: 12015: 12017: 12019: 22020: 22023: 22024: 12025: 2
2005high 3 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 23 · See all
  • K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Cosman Medical, Inc. · 2005 · cites it directly20descendants
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006 · 2 generations on10descendants
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006 · 2 generations on9descendants
  • K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008 · 2 generations on7descendants
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021869Owl Radiofrequency System, Model Urf-2APDiros Technology, Inc.2002—
+1K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit…Cosman Medical, Inc.20053
+2K053415Lesionpoint RF CannulaCosman Medical, Inc.2006—
+2K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.2006—
+2K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.2008—
+3K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200830
201010
201120
201310
201410
201510
201710
201920
202020
202320
202410
202520
FIG. 1 — Lineage of K021869, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (23)

See all 23

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Cosman Medical, Inc.200520
K062758Owl Urf-3APDiros Technology, Inc.20061

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?

  • Of its descendants, K050084 (Cosman Medical, Inc., 2005) has gone furthest, with 20 descendants of its own.

How does its category compare?

All GXD devices

GXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXD

1in 2025

2007: 42008: 22010: 12011: 22017: 22019: 12020: 22022: 12023: 22024: 22025: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXD

185in 2007

2007: 185 days median
2007high 185 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXD

1in 2023

2010: 12016: 12019: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXD

88in 2025

2007: 102008: 102009: 122010: 692011: 892012: 772013: 1192014: 642015: 672016: 512017: 832018: 1562019: 1952020: 1382021: 1542022: 842023: 542024: 632025: 88
2007high 195 (2019) · low 10 (2007)2025

MAUDE reports naming product code GXD, 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
20074185010
20082—010
20090—012
20101—169
20112—089
20120—077
20130—0119
20140—064
20150—067
20160—151
20172—083
20180—0156
20191—1195
20202—0138
20210—0154
20221—084
20232—154
20242—063
20251—088
20260—0—

What is it indicated for?

The OWL Radiofrequency System, Model URF-2AP intended use is for:

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.

Indications for use as stated in the FDA 510(k) statement.

More from Diros Technology, Inc.

8 FDA decisions under this applicant name. See the company

  • K170708Owl RF Insulated CannulaeDiros Technology, Inc. · 2017
  • K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc. · 2015
  • K141586Owl CannulaeDiros Technology, Inc. · 2014
  • K102566Owl CannulaeDiros Technology, Inc. · 2011
  • K110593Owl RF ProbesDiros Technology, Inc. · 2011

Recent decisions in GXD

The GXD category page

  • K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1…Boston Scientific Neuromodulation Corporation · 2025
  • K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc. · 2024
  • K232632Racz Neurostat RF GeneratorEpimed International · 2024
  • K231675OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
  • K220122APEX 6Rf Innovations, Inc. · 2023

https://510kreport.com/device/K021869 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021869: Owl Radiofrequency System, Model Urf-2AP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021869

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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