510(k) · Cleared

Cleared

Sensus Electrode

K121816510(k) TraditionalCleared Nov 26, 2012159-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

Neurometrix, Inc. · GXY Electrode, Cutaneous

Cleared on Nov 26, 2012 as substantially equivalent to K010431 (Lead-Lok, Inc., 2001) after a 159-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.

Decided: Nov 26, 2012
Review: 159 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010431 (2001). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010431 Lead-Lok Reusable Tens/ Nmes ElectrodesLead-Lok, Inc. · 2001
This deviceK121816 Sensus ElectrodeNeurometrix, Inc. · 2012
Descendant · cites it directly · 1 of its ownK140586 Ascend ElectrodeNeurometrix, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK230533 Motive™ ElectrodeCymedica Orthopedics, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all

K140586Ascend ElectrodeNeurometrix, Inc. · 2014 · cites it directly1descendant
K230533Motive™ ElectrodeCymedica Orthopedics, Inc. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010431	Lead-Lok Reusable Tens/ Nmes Electrodes	Lead-Lok, Inc.	2001	—
0 (this device)	K121816	Sensus Electrode	Neurometrix, Inc.	2012	—
+1	K140586	Ascend Electrode	Neurometrix, Inc.	2014	—
+2	K230533	Motive™ Electrode	Cymedica Orthopedics, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2023	1	0

FIG. 1 — Lineage of K121816, 2001–2023Source: 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

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What was it cleared against? (1)

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
*	K010431	Lead-Lok Reusable Tens/ Nmes Electrodes Summary page 2 …Lead-Lok Reusable Neurostimulation Neuro~etrix SENSUS Electrode Electrodes (K010431) Central Characteristics Intended Use The Neurovetrix SENSIJS Electrode is Lead-Lok Reusable Neur…	Lead-Lok, Inc.	2001	—
†	K000870	KM-10 Tens Electrode	Katecho, Inc.	2000	—

Also cleared against K010431: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K140586	Ascend Electrode	Neurometrix, Inc.	2014	1

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?

Its one ancestor has no recall.
Of its descendants, K140586 (Neurometrix, Inc., 2014) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K010431.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

The Neuro~etrix SENSUS Electrode is intended for use as disposable, conductive, adhesive interface between the patient's skin and a transcutaneous, electrical nerve stimulator.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121816: Sensus Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121816

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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