510(k) Report

510(k) · Cleared

Cleared

Modified Leveen Needle Electrode

K962313510(k) TraditionalCleared Sep 11, 199686-day reviewClass II21 CFR 878.4400

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

Radiotherapeutics Corp. · JOS Electrode, Electrosurgical

Cleared on Sep 11, 1996 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 68 later devices descend from it.

Decided
Sep 11, 1996
Review
86 days
Class
Class II
Product code
JOS
Recalls
None
Predicates
0

68 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2008: 2 descendants cleared2006: 2 descendants cleared2007: 2 descendants cleared2003: 3 descendants cleared2016: 4 descendants cleared2004: 1 descendant cleared2009: 4 descendants cleared2010: 2 descendants cleared2015: 5 descendants cleared2018: 3 descendants cleared2011: 1 descendant cleared2023: 7 descendants cleared2024: 8 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2017: 2 descendants cleared2025: 2 descendants cleared2014: 1 descendant cleared2019: 2 descendants cleared2020: 6 descendants cleared2021: 3 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK962313 Modified Leveen Needle ElectrodeRadiotherapeutics Corp. · 1996
  2. Descendant · cites it directly · 67 of its ownK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 50 of its ownK053535 Vivawave Microwave Ablation SystemValleylab · 2006
  4. Descendant · 2 generations on · 41 of its ownK070023 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007
  5. Descendant · 3 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
  6. Descendant · 4 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2002: 12003: 32004: 12006: 22007: 22008: 22009: 42010: 22011: 12012: 22013: 22014: 12015: 52016: 42017: 22018: 32019: 22020: 62021: 32022: 12023: 72024: 82025: 22026: 2
2002high 8 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 68 · See all
  • K011676Vivawave Microwave SystemVivant Medical, Inc. · 2002 · cites it directly67descendants
  • K053535Vivawave Microwave Ablation SystemValleylab · 2006 · 2 generations on50descendants
  • K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007 · 2 generations on41descendants
  • K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · 3 generations on39descendants
  • K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 4 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962313Modified Leveen Needle ElectrodeRadiotherapeutics Corp.1996—
+1K011676Vivawave Microwave SystemVivant Medical, Inc.20021
+2K053535Vivawave Microwave Ablation SystemValleylab2006—
+2K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.2007—
+3K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.2010—
+4K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200330
200410
200620
200720
200820
200940
201020
201110
201220
201320
201410
201550
201640
201720
201830
201920
202060
202130
202210
202370
202480
202520
202620
FIG. 1 — Lineage of K962313, 1996–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (68)

See all 68

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011676Vivawave Microwave SystemVivant Medical, Inc.200267

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, K011676 (Vivant Medical, Inc., 2002) has gone furthest, with 67 descendants of its own.

How does its category compare?

All JOS devices

JOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOS

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

Recalls per year · JOS

2in 2019

2008: 12012: 22016: 12019: 2
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JOS

6in 2025

2007: 292008: 372009: 622010: 142011: 52012: 72013: 52014: 72015: 132016: 62017: 72018: 102019: 172020: 122021: 52022: 82023: 92024: 32025: 6
2007high 62 (2009) · low 3 (2024)2025

MAUDE reports naming product code JOS, 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—029
20080—137
20090—062
20100—014
20110—05
20120—27
20130—05
20140—07
20150—013
20161—16
20170—07
20180—010
20190—217
20200—012
20210—05
20220—08
20230—09
20240—03
20250—06
20260—0—

More from Radiotherapeutics Corp.

12 FDA decisions under this applicant name. See the company

  • K011220Leveen Reflect Monopolar/Bipolar Needle ElectrodeRadiotherapeutics Corp. · 2002
  • K012315Leveen ElectrodeRadiotherapeutics Corp. · 20012 recalls
  • K000241Radiotherapeutics RF 3000 Radiofrequency GeneratorRadiotherapeutics Corp. · 2000
  • K982556Leveen Needle ElectrodeRadiotherapeutics Corp. · 200011 recalls
  • K000032Leveen Needle ElectrodeRadiotherapeutics Corp. · 20003 recalls

Recent decisions in JOS

The JOS category page

  • K161600Resection ElectrodesOlympus Winter & Ibe GmbH · 2016
  • K050923Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorConmed Linvatec · 20051 recall
  • K012684Reprocessed Electrosurgical ElectrodeSterilmed, Inc. · 20021 recall
  • K011515Medline Grounding PadMedline Industries, Inc. · 2001
  • K003403Endoscopic Monopolareectrode, Model Eme- 1000 to 1999Highland / Marietta, Inc. · 2001

https://510kreport.com/device/K962313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962313: Modified Leveen Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962313

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026