510(k) · Cleared
ClearedINTERX500 Flexible Array Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Resource Group, Inc. · GXY Electrode, Cutaneous
Cleared on Mar 29, 2006 as substantially equivalent to K042912 (Neuro Resource Group, Inc., 2005) after a 91-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Mar 29, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951951 (1996). 4 ancestors in all, the oldest K870947 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK951951 Focus Model 795 UnitEmpi · 1996
- 2 generations backK041575 Fenzian Treatment SystemEumedic Limited · 2004
- 1 generation backK042912 INTERX5000Neuro Resource Group, Inc. · 2005 · Recalled
- This deviceK053626 INTERX500 Flexible Array ElectrodeNeuro Resource Group, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK071878 Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS…Med-Lectric Corporation · 2007
Most influential descendants
Showing 1 of 1 · See all- K071878Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS RehabMed-Lectric Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951951 | Focus Model 795 Unit | Empi | 1996 | — |
| −2 | K041575 | Fenzian Treatment System | Eumedic Limited | 2004 | — |
| −1 | K042912 | INTERX5000 | Neuro Resource Group, Inc. | 2005 | 1 |
| 0 (this device) | K053626 | INTERX500 Flexible Array Electrode | Neuro Resource Group, Inc. | 2006 | — |
| +1 | K071878 | Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS Rehab | Med-Lectric Corporation | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K042912 | INTERX5000Summary page 1…ication: Classification Regulation: 882.1320 Panel: Neurology, Physical Medicine Product Code: GXY Trade Namne(s): InterX 500 Flexible Array Electrode Predicate Device: K042912-InterX 5000 Description: The lnterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071878 | Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS Rehab | 2007 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K071878 (Med-Lectric Corporation, 2007) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K042912.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 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 InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053626: INTERX500 Flexible Array Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053626
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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