510(k) Report

510(k) · Cleared

Cleared

Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay

K002389510(k) TraditionalCleared Oct 23, 200080-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

Baylis Medical Co., Inc. · GXI Probe, Radiofrequency Lesion

Cleared on Oct 23, 2000 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 25 later devices descend from it.

Decided
Oct 23, 2000
Review
80 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
0

25 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2019: 2 descendants cleared2007: 3 descendants cleared2016: 2 descendants cleared2006: 1 descendant cleared2017: 2 descendants cleared2009: 2 descendants cleared2008: 1 descendant cleared2026: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2012: 1 descendant cleared2024: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared2022: 2 descendants cleared200020052010201520202025
  1. This deviceK002389 Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management…Baylis Medical Co., Inc. · 2000
  2. Descendant · cites it directly · 17 of its ownK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
  3. Descendant · cites it directly · 11 of its ownK053082 Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
  5. Descendant · 2 generations on · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
  6. Descendant · 3 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 32008: 12009: 22012: 12014: 12015: 12016: 22017: 22018: 12019: 22020: 12022: 22024: 12025: 12026: 1
2005high 3 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 25 · See all
  • K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005 · cites it directly17descendants
  • K053082Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc. · 2005 · cites it directly11descendants
  • K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · 2 generations on7descendants
  • K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · 2 generations on5descendants
  • K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002389Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector…Baylis Medical Co., Inc.2000—
+1K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments2005—
+1K053082Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc.20052
+2K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems2016—
+2K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments2006—
+3K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200730
200810
200920
201210
201410
201510
201620
201720
201810
201920
202010
202220
202410
202510
202610
FIG. 1 — Lineage of K002389, 2000–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments200517
K053082Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc.200511
K181864Polaris RF Ablation SystemBaylis Medical Company, Inc.20190
K071745Baylis Pain Management Single-Use ProbeBaylis Medical Co., Inc.20070

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, K043442 (Stryker Instruments, 2005) has gone furthest, with 17 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 Baylis Medical Co., Inc.

28 FDA decisions under this applicant name. See the company

  • K122926Sureflex Steerable Guiding Sheath KitBaylis Medical Co., Inc. · 2013
  • K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc. · 2012
  • K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 20111 Class I recall
  • K102192Indiscal Digital ManometerBaylis Medical Co., Inc. · 2011
  • K101372Duocool Pain Management Probe, Model Osp-17-180-20Baylis Medical Co., Inc. · 2010

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/K002389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002389

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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