510(k) Report

510(k) · Cleared

Cleared

Radionics Pole Needles

K021942510(k) TraditionalCleared Sep 11, 200290-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

Radionics, A Division of Tyco Healthcare Group LP · GXI Probe, Radiofrequency Lesion

Cleared on Sep 11, 2002 as substantially equivalent to K870028 (Radionics, Inc., 1987) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1987. 15 later devices descend from it.

Decided
Sep 11, 2002
Review
90 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K870028 (1987). 15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2006: 3 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. · 19981990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants K980430 · 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 · 3 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 2 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 1 generation backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. This deviceK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
  5. Descendant · cites it directly · 12 of its ownK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
  6. Descendant · 2 generations on · 10 of its ownK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  7. Descendant · 2 generations on · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  8. Descendant · 3 generations on · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
  9. Descendant · 3 generations on · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004: 22006: 32008: 22011: 12013: 12014: 12015: 12017: 12019: 12020: 12026: 1
2004high 3 (2006) · low 0 (2005)2026

Most influential descendants

Showing 5 of 15 · See all
  • K042375SMK, CX, Cxe, RCNTechnomed Europe · 2004 · cites it directly12descendants
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006 · 2 generations on10descendants
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006 · 2 generations on9descendants
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · 3 generations on4descendants
  • K102566Owl CannulaeDiros Technology, Inc. · 2011 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200630
200820
201110
201310
201410
201510
201710
201910
202010
202610
FIG. 1 — Lineage of K021942, 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? (3)

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
*K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible
Summary page 1
…SIFICATION CODE: 21 C.F.R. 9 882.4725 PREDICATE DEVICE: SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles, K870028; RSM-C, Sluijter-Mehta Cannula, K963577 Radionics Disposable RF Cannula…
Radionics, Inc.1987—
*K963577Radionics Sluijter-Mehta Cannula
Summary page 1
…SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles, K870028; RSM-C, Sluijter-Mehta Cannula, K963577 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS), K9 80430 INTE…
Radionics, Inc.1996—
*K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)
Summary page 1
…RSM-C, Sluijter-Mehta Cannula, K963577 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS), K9 80430 INTENDED USE: A Pole Needle is an injection needle, which may be used either for per…
Radionics, Inc.1998—

Also cleared against K870028: 7 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K042375SMK, CX, Cxe, RCNTechnomed Europe200412
K060397RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast…PAJUNK GmbH Medizintechnologie20060
K040565Physician Industries Radiofrequency Ablation NeedlePhysician Industries, Inc.20040

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 15 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K042375 (Technomed Europe, 2004) has gone furthest, with 12 descendants of its own.
  • 7 other devices also cite its predicate K870028.

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 Pole 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 injecting 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 K870028

7 other devices cite the same predicate.

  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
  • K062946Top Neuropole Needles, Models ST, X, RC, XE and TLTop Corp. · 2007
  • K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal…Cosman Medical, Inc. · 20053 recalls
  • K042375SMK, CX, Cxe, RCNTechnomed Europe · 2004
  • K034012Smith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc. · 20043 recalls
  • K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998

More from Radionics, A Division of Tyco…

8 FDA decisions under this applicant name. See the company

  • K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
  • K041997Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP · 2004
  • K032054Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 2003
  • K023519Radionics Varilink 2Radionics, A Division of Tyco Healthcare Group LP · 2003
  • K013661Xplan 2.2 with the Body SystemRadionics, A Division of Tyco Healthcare Group LP · 2001

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/K021942 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021942: Radionics Pole Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021942

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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