510(k) Report

510(k) · Cleared

Cleared

Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International)

K020354510(k) TraditionalCleared May 3, 200288-day reviewClass II21 CFR 882.4400

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. · GXD Generator, Lesion, Radiofrequency

Cleared on May 3, 2002 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
May 3, 2002
Review
88 days
Class
Class II
Product code
GXD
Recalls
None
Predicates
0

8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2024: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK020354 Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic)…Baylis Medical Co., Inc. · 2002
  2. Descendant · cites it directly · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
  3. Descendant · 2 generations on · 4 of its ownK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
  4. Descendant · 3 generations on · 3 of its ownK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
  5. Descendant · cites it directly · 1 of its ownK062758 Owl Urf-3APDiros Technology, Inc. · 2006
  6. Descendant · 4 generations on · 0 of its ownK241621 Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006: 22009: 12010: 12012: 12014: 12015: 12024: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · 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
  • K062758Owl Urf-3APDiros Technology, Inc. · 2006 · cites it directly1descendant
  • K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020354Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230…Baylis Medical Co., Inc.2002—
+1K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments2006—
+2K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc.2009—
+3K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/…Olsen Medical20122
+1K062758Owl Urf-3APDiros Technology, Inc.2006—
+4K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200910
201010
201210
201410
201510
202410
FIG. 1 — Lineage of K020354, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXD? 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 GXD device

  1. #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments20065
K062758Owl Urf-3APDiros Technology, Inc.20061

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, K061660 (Stryker Instruments, 2006) has gone furthest, with 5 descendants of its own.

How does its category compare?

All GXD devices

GXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXD

1in 2025

2007: 42008: 22010: 12011: 22017: 22019: 12020: 22022: 12023: 22024: 22025: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXD

185in 2007

2007: 185 days median
2007high 185 (2007)2026

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

Recalls per year · GXD

1in 2023

2010: 12016: 12019: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXD

88in 2025

2007: 102008: 102009: 122010: 692011: 892012: 772013: 1192014: 642015: 672016: 512017: 832018: 1562019: 1952020: 1382021: 1542022: 842023: 542024: 632025: 88
2007high 195 (2019) · low 10 (2007)2025

MAUDE reports naming product code GXD, 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
20074185010
20082—010
20090—012
20101—169
20112—089
20120—077
20130—0119
20140—064
20150—067
20160—151
20172—083
20180—0156
20191—1195
20202—0138
20210—0154
20221—084
20232—154
20242—063
20251—088
20260—0—

What is it indicated for?

Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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 GXD

The GXD category page

  • K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1…Boston Scientific Neuromodulation Corporation · 2025
  • K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc. · 2024
  • K232632Racz Neurostat RF GeneratorEpimed International · 2024
  • K231675OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
  • K220122APEX 6Rf Innovations, Inc. · 2023

https://510kreport.com/device/K020354 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020354: Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020354

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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