510(k) · Cleared

Recalled · Class II · 2012

Reusable Tens Paravertebral Pad #641 Back Electrod

K901575510(k) TraditionalCleared May 2, 199029-day reviewClass II21 CFR 882.1320Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pioneering Technologies, Inc. · GXY Electrode, Cutaneous

Cleared on May 2, 1990 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.

Decided: May 2, 1990
Review: 29 days
Class: Class II
Product code: GXY
Recalls: 1
Predicates: 0

9 later devices descend from it, 1 citing it directly.

This deviceK901575 Reusable Tens Paravertebral Pad #641 Back ElectrodPioneering Technologies, Inc. · 1990
Descendant · cites it directly · 8 of its ownK983097 Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999
Descendant · 2 generations on · 6 of its ownK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
Descendant · 3 generations on · 4 of its ownK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
Descendant · 4 generations on · 3 of its ownK083756 Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
Descendant · 4 generations on · 1 of its ownK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1999high 1 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 9 · See all

K983097Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999 · cites it directly8descendants
K070807Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007 · 2 generations on6descendants
K080386Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008 · 3 generations on4descendants
K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009 · 4 generations on3descendants
K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 2012 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K901575	Reusable Tens Paravertebral Pad #641 Back Electrod	Pioneering Technologies, Inc.	1990	—
+1	K983097	Tens/Fes/Nmes Electrodes	Uni-Patch, Inc.	1999	—
+2	K070807	Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes	Pepin Mfg., Inc.	2007	—
+3	K080386	Columbia 600 Electrode, Columbia 06 Leadwire	Columbia Scientific Development, LLC	2008	—
+4	K083756	Guardian 150 Electrode	Selectivemed Components, Inc.	2009	—
+4	K121483	Reusable Cutaneous Electrode	Ampcare, LLC	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	1	0
2007	1	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2013	1	0
2018	1	0

FIG. 1 — Lineage of K901575, 1990–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GXY? 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 GXY device

#1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983097	Tens/Fes/Nmes Electrodes	Uni-Patch, Inc.	1999	8

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 9, 2012	Class II	Z-0498-2013	Employee error	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K983097 (Uni-Patch, Inc., 1999) has gone furthest, with 8 descendants of its own.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXY

6in 2025

2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007high 203 (2014) · low 81 (2022)2026

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

Recalls per year · GXY

2in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · GXY

58in 2025

2007high 58 (2025) · low 10 (2018)2025

MAUDE reports naming product code GXY, 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	7	88	0	14
2008	9	136	0	17
2009	17	159	4	15
2010	3	137	1	14
2011	6	183	5	16
2012	9	150	4	16
2013	7	99	0	15
2014	9	203	0	11
2015	6	119	0	19
2016	6	170	0	15
2017	9	116	0	11
2018	14	135	0	10
2019	9	113	0	19
2020	4	108	0	11
2021	12	195	0	21
2022	5	81	0	34
2023	13	132	2	25
2024	7	111	0	51
2025	6	148	0	58
2026	12	70	0	—

https://510kreport.com/device/K901575 · printed Nov 4, 2026

Cite this page

510(k) Report. “K901575: Reusable Tens Paravertebral Pad #641 Back Electrod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K901575

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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