510(k) · Cleared

Cleared

Inspirstar Glove Electrode

K061343510(k) TraditionalCleared May 31, 200616-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

Inspirstar, Inc. · GXY Electrode, Cutaneous

Cleared on May 31, 2006 as substantially equivalent to K053214 (Neurotron Medical, 2005) after a 16-day review. Its family tree reaches back 2 generations to 1994.

Decided: May 31, 2006
Review: 16 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K932299 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
1 generation backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
This deviceK061343 Inspirstar Glove ElectrodeInspirstar, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K932299	Electro-Mesh	Prizm Medical, Inc.	1994	—
−1	K053214	Theraknit Garment Electrode	Neurotron Medical	2005	—
0 (this device)	K061343	Inspirstar Glove Electrode	Inspirstar, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

FIG. 1 — Lineage of K061343, 1994–2006Source: 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? (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
*	K053214	Theraknit Garment Electrode Summary page 2 …Table 5-1 Predicate Device Device Name Manufacturer 510(k) No. Date Cleared TheraKnit Garment Neurotron Medical, K053214 12/20/2005 Electrode Inc 6. Substantial Equivalence Summary Inspirstar Glove Electrode has the…	Neurotron Medical	2005	—

Also cleared against K053214: 5 other devices →

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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
None of the 4 ancestors has a recall.
5 other devices also cite its predicate K053214.

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?

Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061343 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061343: Inspirstar Glove Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061343

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