510(k) · Cleared

Cleared

M & R Disposable Electrode (14200)

K963236510(k) TraditionalCleared Nov 15, 199688-day reviewClass II21 CFR 882.1320

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

M & R Mfg., Inc. · GXY Electrode, Cutaneous

Cleared on Nov 15, 1996 as substantially equivalent to K851303 (Medtronic Vascular, 1985) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1985.

Decided: Nov 15, 1996
Review: 88 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K851303 (1985). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK851303 Comfort-Ease ElectrodeMedtronic Vascular · 1985
This deviceK963236 M & R Disposable Electrode (14200)M & R Mfg., Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851303	Comfort-Ease Electrode	Medtronic Vascular	1985	—
0 (this device)	K963236	M & R Disposable Electrode (14200)	M & R Mfg., Inc.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K963236, 1985–1996Source: 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 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? (2)

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
*	K851303	Comfort-Ease Electrode Summary page 2 …49 0s Device Characteristic M & R Manufacturing., Inc. M&R Disposable TENS & NMES Electrodes Medtronic ComfortEase Disposable TENS & NMES Electrodes - K851303 Medical Designs, Inc. Protector Disposable TENS & NMES Electrodes - K911366A Number of Models 1 model* 3 models 4 models El…	Medtronic Vascular	1985	—
*	K911366	Protector Disposable Tens and Nmes Electrode Summary page 2 …Disposable TENS & NMES Electrodes Medtronic ComfortEase Disposable TENS & NMES Electrodes - K851303 Medical Designs, Inc. Protector Disposable TENS & NMES Electrodes - K911366A Number of Models 1 model* 3 models 4 models Electrode Sizes (in.)/ Shapes 2.0 x 2.25 in. (rectangle) * Additional models…	Medical Design & Manufacturing Corp.	1991	—

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.

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	—

What is it indicated for?

M&R Disposable Electrodes are intended for single-patient/single-application use in TENS (“traditional” TENS, microcurrent TENS, etc.) and NMES (“traditional” NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963236: M & R Disposable Electrode (14200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963236

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