510(k) Report

510(k) · Cleared

Cleared

Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta Intermediate Cable (Ryan-C, -R, -B)

K090608510(k) TraditionalCleared Jun 14, 2010465-day reviewClass II21 CFR 882.4725

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

Minta Medical Limited · GXI Probe, Radiofrequency Lesion

Cleared on Jun 14, 2010 as substantially equivalent to K011387 (Eurolink, LLC, 2001) after a 465-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jun 14, 2010
Review
465 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011387 (2001). No later device cites it as a predicate yet.

K011387 · Neurotherm, Model JK4 · Eurolink, LLC · 2001 · recalled2000200220042006200820102012
K011387 · Neurotherm, Model JK4 · Eurolink, LLC · 2001 · recalled0
  1. Root · 1 generation backK011387 Neurotherm, Model JK4Eurolink, LLC · 2001 · Recalled
  2. This deviceK090608 Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200)…Minta Medical Limited · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011387Neurotherm, Model JK4Eurolink, LLC20011
0 (this device)K090608Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta…Minta Medical Limited2010—
FIG. 1 — Lineage of K090608, 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), 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 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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K011387Neurotherm, Model JK4
Summary page 1
…over fifteen years in the UK and other countries around the world including the U.S.A. previously labelled as Neurotherm (K011387). (Minta Medical Registration No. 3004617090, owner/operator Number 9064097).…
Eurolink, LLC20011

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?

  • Its one ancestor has a recall.

How does its category compare?

All GXI devices

GXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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—

What is it indicated for?

The Minta Radiofrequency Thermocouple Electrodes are indicated for use in the lesioning of peripheral nerve tissue.

Indications for use as stated in the FDA summary.

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/K090608 · printed Nov 3, 2026

Cite this page

510(k) Report. “K090608: Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta Intermediate Cable (Ryan-C, -R, -B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090608

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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