510(k) Report

510(k) · Cleared

Cleared

SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible

K870028510(k) TraditionalCleared Oct 26, 1987294-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, Inc. · GXI Probe, Radiofrequency Lesion

Cleared on Oct 26, 1987 after a 294-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 111 later devices descend from it.

Decided
Oct 26, 1987
Review
294 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
0

111 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2004: 5 descendants cleared1996: 1 descendant cleared2002: 2 descendants cleared2005: 1 descendant cleared2008: 5 descendants cleared1998: 1 descendant cleared2007: 3 descendants cleared2006: 6 descendants cleared2026: 5 descendants cleared2025: 6 descendants cleared2019: 7 descendants cleared2011: 2 descendants cleared2012: 3 descendants cleared2013: 2 descendants cleared2014: 2 descendants cleared2009: 2 descendants cleared2023: 11 descendants cleared2015: 4 descendants cleared2017: 5 descendants cleared2020: 10 descendants cleared2024: 15 descendants cleared2010: 1 descendant cleared2022: 3 descendants cleared2016: 3 descendants cleared2018: 3 descendants cleared2021: 3 descendants cleared1990200020102020
  1. This deviceK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. Descendant · cites it directly · 109 of its ownK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. Descendant · cites it directly · 108 of its ownK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. Descendant · 2 generations on · 76 of its ownK021329 Rita SystemRita Medical Systems · 2002
  5. Descendant · 3 generations on · 75 of its ownK042216 Cool-Tip RF Ablation SystemValleylab · 2004
  6. Descendant · 4 generations on · 56 of its ownK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

1996: 11998: 12002: 22004: 52005: 12006: 62007: 32008: 52009: 22010: 12011: 22012: 32013: 22014: 22015: 42016: 32017: 52018: 32019: 72020: 102021: 32022: 32023: 112024: 152025: 62026: 5
1996high 15 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 111 · See all
  • K963577Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996 · cites it directly109descendants
  • K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998 · cites it directly108descendants
  • K021329Rita SystemRita Medical Systems · 2002 · 2 generations on76descendants
  • K042216Cool-Tip RF Ablation SystemValleylab · 2004 · 3 generations on75descendants
  • K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 4 generations on56descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
+1K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
+1K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
+2K021329Rita SystemRita Medical Systems2002—
+3K042216Cool-Tip RF Ablation SystemValleylab2004—
+4K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200220
200450
200510
200660
200730
200850
200920
201010
201120
201230
201320
201420
201540
201630
201750
201830
201970
2020100
202130
202230
2023110
2024150
202560
202650
FIG. 1 — Lineage of K870028, 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (111)

See all 111

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

NumberDeviceApplicantDecidedDescendants
K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996109
K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998108
K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Cosman Medical, Inc.200520
K034012Smith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc.200415
K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP200215
K042375SMK, CX, Cxe, RCNTechnomed Europe200412
K062946Top Neuropole Needles, Models ST, X, RC, XE and TLTop Corp.20075
K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.20084

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, K963577 (Radionics, Inc., 1996) has gone furthest, with 109 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—

More from Radionics, Inc.

56 FDA decisions under this applicant name. See the company

  • K030697Radionics Single Use Ground Pad (DGP-HP)Radionics, Inc. · 20031 recall
  • K001741Radionics RF Disc Catheter Electrode SystemRadionics, Inc. · 2000
  • K002773Neuromap with Neuro 100Radionics, Inc. · 2000
  • K992226XDS External CSF Drainage and Monitoring SystemRadionics, Inc. · 2000
  • K001950Optical Tracking System (Ots)Radionics, Inc. · 2000

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/K870028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870028

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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