510(k) Report

510(k) · Cleared

Cleared

SMK, CX, Cxe, RCN

K042375510(k) TraditionalCleared Oct 26, 200455-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

Technomed Europe · GXI Probe, Radiofrequency Lesion

Cleared on Oct 26, 2004 as substantially equivalent to K021942 (Radionics, A Division of Tyco Healthcare Group LP, 2002) and 3 other predicates after a 55-day review. Its family tree reaches back 4 generations to 1987. 12 later devices descend from it.

Decided
Oct 26, 2004
Review
55 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K870028 (1987). 12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2026: 1 descendant cleared2008: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant clearedK870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 1987K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K021942 · Radionics Pole Needles · Radionics, A Division of Tyco Healthcare Group LP · 20021990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants K021942 · Radionics Pole Needles · Radionics, A Division of Tyco Healthcare Group LP · 2002K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 19870
  1. Root · 4 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 3 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 2 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. 1 generation backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
  5. This deviceK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
  6. Descendant · cites it directly · 10 of its ownK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  7. Descendant · cites it directly · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  8. Descendant · 2 generations on · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
  9. Descendant · 2 generations on · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011
  10. Descendant · cites it directly · 3 of its ownK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006: 22008: 22011: 12013: 12014: 12015: 12017: 12019: 12020: 12026: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006 · cites it directly10descendants
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006 · cites it directly9descendants
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · 2 generations on4descendants
  • K102566Owl CannulaeDiros Technology, Inc. · 2011 · 2 generations on3descendants
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−3K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−2K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
−1K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP2002—
0 (this device)K042375SMK, CX, Cxe, RCNTechnomed Europe2004—
+1K053415Lesionpoint RF CannulaCosman Medical, Inc.2006—
+1K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.2006—
+2K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.2008—
+2K102566Owl CannulaeDiros Technology, Inc.2011—
+1K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200820
201110
201310
201410
201510
201710
201910
202010
202610
FIG. 1 — Lineage of K042375, 1987–2026Source: 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
Get a 510(k) Report

What was it cleared against? (4)

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
*K021942Radionics Pole Needles
Summary page 1
…nula for radio frequency electrode Classification Name: Radiofrequency lesion probe (21 CFR section 882.4725) Substantial Equivalence: K021942: Radionics Pole Needles K980430: Radionics disposable RF Cannulae (SC-C, RFK-…
Radionics, A Division of Tyco Healthcare Group LP2002—
*K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)
Summary page 1
…Radiofrequency lesion probe (21 CFR section 882.4725) Substantial Equivalence: K021942: Radionics Pole Needles K980430: Radionics disposable RF Cannulae (SC-C, RFK- DB, RFK-DS)…
Radionics, Inc.1998—
*K963577Radionics Sluijter-Mehta Cannula
Summary page 1
…edles K980430: Radionics disposable RF Cannulae (SC-C, RFK- DB, RFK-DS) K963577: RSM-C, Sluijter-Mehta Cannula K870028: SMK Sluijter-Mehta Cannulae, RF Pole, Pole and…
Radionics, Inc.1996—
*K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible
Summary page 1
…Cannulae (SC-C, RFK- DB, RFK-DS) K963577: RSM-C, Sluijter-Mehta Cannula K870028: SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles Device description:…
Radionics, Inc.1987—

Also cleared against K021942: 2 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K053415Lesionpoint RF CannulaCosman Medical, Inc.200610
K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.20069
K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.20083
K253907Disposable Radiofrequency CannulaAbbott Medical20260

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 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K053415 (Cosman Medical, Inc., 2006) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K021942.

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—

What is it indicated for?

A RF Injection Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injection contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radiofrequency lesion may be made.

Indications for use as stated in the FDA summary.

Also cleared against K021942

2 other devices cite the same predicate.

  • K060397RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast Cannula, Cannula, Facet…PAJUNK GmbH Medizintechnologie · 2006
  • K040565Physician Industries Radiofrequency Ablation NeedlePhysician Industries, Inc. · 2004

More from Technomed Europe

13 FDA decisions under this applicant name. See the company

  • K254183MR Conditional Cup ElectrodesTechnomed Europe · 2026
  • K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode…Technomed Europe · 2026
  • K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
  • K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,Technomed Europe · 20132 recalls
  • K121257Laryngeal ElectrodeTechnomed Europe · 2012

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/K042375 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042375: SMK, CX, Cxe, RCN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042375

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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