510(k) · Cleared

Cleared

Interx Sterile Self-Adhesive Dual Electrode (Issde)

K130816510(k) TraditionalCleared Jun 21, 201388-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

Neuro Resource Group, Inc. · GXY Electrode, Cutaneous

Cleared on Jun 21, 2013 as substantially equivalent to K083350 (Covidien LP, 2009) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1990.

Decided: Jun 21, 2013
Review: 88 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K900997 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK900997 K-Sterile Tens ElectrodesKatecho, Inc. · 1990
This deviceK130816 Interx Sterile Self-Adhesive Dual Electrode (Issde)Neuro Resource Group, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900997	K-Sterile Tens Electrodes	Katecho, Inc.	1990	—
0 (this device)	K130816	Interx Sterile Self-Adhesive Dual Electrode (Issde)	Neuro Resource Group, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
2009	1	0

FIG. 1 — Lineage of K130816, 1990–2013Source: 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
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What was it cleared against? (3)

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
*	K083350	Tens/Nmes/Fes Stimulating Electrode Summary page 1 …on Panel: Neurology Predicate Device Information: 7 1. Device Name: Superior StarBurst TENS/NMES/FES Stimulating Electrodes Manufacturer: Covidien, LP 510(k) Reference: K083350 2. Device Name: Sterile Post Operative Electrodes Self-Adhering Manufacturer: Covidien 510(k) Reference: K900997 (510(k) holder:…	Covidien LP	2009	—
*	K900997	K-Sterile Tens Electrodes Summary page 1 …Electrodes Manufacturer: Covidien, LP 510(k) Reference: K083350 2. Device Name: Sterile Post Operative Electrodes Self-Adhering Manufacturer: Covidien 510(k) Reference: K900997 (510(k) holder: Katecho, Inc.) 3. Device Name: Reusable and Self-Adhering TENS.NMES.FES Stimulating Electrodes (Classic # 2404)…	Katecho, Inc.	1990	—
*	K900519	Classic Ecg/Stimulating NO. 1700 Series Summary page 1 …10(k) holder: Katecho, Inc.) 3. Device Name: Reusable and Self-Adhering TENS.NMES.FES Stimulating Electrodes (Classic # 2404) : Manufacturer: Covidien 510(k) Reference: K900519 (510(k) holder: Classic Medical Products, Inc.) Product Description: The Proposed ISSDE is a flexible, sterile laminate compose…	Classic Medical Products, Inc.	1990	1

Also cleared against K083350: 1 other device →

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?

1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K083350.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient’s skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use.

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/K130816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130816: Interx Sterile Self-Adhesive Dual Electrode (Issde).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130816

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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