510(k) Report

510(k) · Cleared

Recalled · 2008

Neurotherm, Model JK4

K011387510(k) TraditionalCleared Sep 6, 2001122-day reviewClass II21 CFR 882.4725Recalls 1

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

Eurolink, LLC · GXI Probe, Radiofrequency Lesion

Cleared on Sep 6, 2001 after a 122-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Sep 6, 2001
Review
122 days
Class
Class II
Product code
GXI
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared200020052010201520202025
  1. This deviceK011387 Neurotherm, Model JK4Eurolink, LLC · 2001
  2. Descendant · cites it directly · 0 of its ownK090608 Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200)…Minta Medical Limited · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K090608Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta Intermediate…Minta Medical Limited · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011387Neurotherm, Model JK4Eurolink, LLC2001—
+1K090608Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta…Minta Medical Limited2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K011387, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GXI? 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 GXI device

  1. #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K090608Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta Intermediate…Minta Medical Limited20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 28, 2008Not classifiedZ-0838-2009Labeling designDistal tip may detach from the probe

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K090608 (Minta Medical Limited, 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GXI devices

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

FDA decisions per year · GXI

4in 2025

2007: 42008: 22009: 22010: 22011: 32012: 12013: 12014: 12015: 12016: 32017: 32018: 12019: 32020: 32022: 22025: 42026 (partial year): 2
2007high 4 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXI

183in 2025

2007: 87 days median2011: 64 days median2016: 240 days median2017: 125 days median2019: 63 days median2020: 255 days median2025: 183 days median
2007high 255 (2020) · low 63 (2019)2026

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

Recalls per year · GXI

1in 2019

2007: 32008: 12010: 12012: 12013: 12017: 12019: 12026 (partial year): 3
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GXI

98in 2025

2007: 12008: 42009: 102010: 82011: 52012: 142013: 252014: 202015: 232016: 162017: 1502018: 1472019: 932020: 312021: 302022: 462023: 352024: 452025: 98
2007high 150 (2017) · low 1 (2007)2025

MAUDE reports naming product code GXI, 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
200748731
20082—14
20092—010
20102—18
201136405
20121—114
20131—125
20141—020
20151—023
20163240016
201731251150
20181—0147
2019363193
20203255031
20210—030
20222—046
20230—035
20240—045
20254183098
20262—3—

Recent decisions in GXI

The GXI category page

  • K253907Disposable Radiofrequency CannulaAbbott Medical · 2026
  • K251802STAR RF Ablation SystemMerit Medical Systems, Inc. · 2026
  • K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025
  • K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)Abbott Medical · 2025
  • K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve…Stryker Instruments · 2025

https://510kreport.com/device/K011387 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011387: Neurotherm, Model JK4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011387

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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