510(k) · Cleared

Recalled · Class II · 2016

Baylis Pain Management Cooled Probe, Model PMPC-18-150-6

K053082510(k) SpecialCleared Nov 30, 200528-day reviewClass II21 CFR 882.4725Recalls 2

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 Nov 30, 2005 as substantially equivalent to K002389 (Baylis Medical Co., Inc., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000. 11 later devices descend from it. It has been recalled 2 times.

Decided: Nov 30, 2005
Review: 28 days
Class: Class II
Product code: GXI
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K002389 (2000). 11 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK002389 Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management…Baylis Medical Co., Inc. · 2000
This deviceK053082 Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc. · 2005
Descendant · cites it directly · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
Descendant · 2 generations on · 4 of its ownK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
Descendant · 3 generations on · 3 of its ownK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
Descendant · cites it directly · 3 of its ownK062937 Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1…Baylis Medical Co., Inc. · 2007 · Recalled
Descendant · cites it directly · 1 of its ownK163461 Coolief* Cooled RF ProbeHalyard Health, Inc. · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006high 1 (2006) · low 0 (2008)2026

Most influential descendants

Showing 5 of 11 · See all

K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · cites it directly5descendants
K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009 · 2 generations on4descendants
K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical · 2012 · 3 generations on3descendants
K062937Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1…Baylis Medical Co., Inc. · 2007 · cites it directly3descendants
K163461Coolief* Cooled RF ProbeHalyard Health, Inc. · 2017 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002389	Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector…	Baylis Medical Co., Inc.	2000	—
0 (this device)	K053082	Baylis Pain Management Cooled Probe, Model PMPC-18-150-6	Baylis Medical Co., Inc.	2005	—
+1	K061660	Stryker RF Parallel Bipolar Adaptor Cable	Stryker Instruments	2006	—
+2	K083528	Smith & Nephew Bipolar Adapter Cable, Model 72200022	Smith & Nephew, Inc.	2009	—
+3	K111262	Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/…	Olsen Medical	2012	2
+1	K062937	Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1…	Baylis Medical Co., Inc.	2007	1
+1	K163461	Coolief* Cooled RF Probe	Halyard Health, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2009	1	0
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2020	1	0
2024	1	0

FIG. 1 — Lineage of K053082, 2000–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002389	Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector… Summary page 1 …GXI Identification of Predicate IDevice Predicate dev~\ice is the Baxilis Pain MIanagementil Probe. N\ hi ch is Cceared under1C I )k) Prermarket Notification N umlber K002 389. Dev ice Description TheC BavIis P3aini N an aoemen t Cooled ProI0beC is a ster-Ie. smI 11Leuse dei ce IthC eIIvevsCI…	Baylis Medical Co., Inc.	2000	—

Also cleared against K002389: 3 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K061660	Stryker RF Parallel Bipolar Adaptor Cable	Stryker Instruments	2006	5
K062937	Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1…	Baylis Medical Co., Inc.	2007	3
K163461	Coolief* Cooled RF Probe	Halyard Health, Inc.	2017	1
K181864	Polaris RF Ablation System	Baylis Medical Company, Inc.	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 16, 2016	Class II	Z-2391-2016	Process control	Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
May 12, 2010	Not classified	Z-1755-2010	Error in labeling	Name of the device reflected on the product packing sleeve is incorrect.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K061660 (Stryker Instruments, 2006) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K002389.

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

2007high 4 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXI

183in 2025

2007high 255 (2020) · low 63 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXI

1in 2019

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	87	3	1
2008	2	—	1	4
2009	2	—	0	10
2010	2	—	1	8
2011	3	64	0	5
2012	1	—	1	14
2013	1	—	1	25
2014	1	—	0	20
2015	1	—	0	23
2016	3	240	0	16
2017	3	125	1	150
2018	1	—	0	147
2019	3	63	1	93
2020	3	255	0	31
2021	0	—	0	30
2022	2	—	0	46
2023	0	—	0	35
2024	0	—	0	45
2025	4	183	0	98
2026	2	—	3	—

What is it indicated for?

Baylis Pain management Cooled Probe will be used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053082 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053082

Report an extraction error

Are you the manufacturer?

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