510(k) · Cleared

Cleared

Transdiscal System (Transdiscal Probe), Model TDP-17-150-6

K031951510(k) TraditionalCleared Sep 11, 200379-day reviewClass II21 CFR 878.4400

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. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 11, 2003 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided: Sep 11, 2003
Review: 79 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

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

This deviceK031951 Transdiscal System (Transdiscal Probe), Model TDP-17-150-6Baylis Medical Co., Inc. · 2003
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 · 2 generations on · 1 of its ownK163236 COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 1 (2006) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · 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
K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031951	Transdiscal System (Transdiscal Probe), Model TDP-17-150-6	Baylis Medical Co., Inc.	2003	—
+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
+2	K163236	COOLIEF Cooled Radiofrequency Kit	Halyard Health, Inc.	2016	—

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
2019	1	0
2020	1	0
2024	1	0

FIG. 1 — Lineage of K031951, 2003–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

2 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

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 GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K031951 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031951: Transdiscal System (Transdiscal Probe), Model TDP-17-150-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031951

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