510(k) · Cleared
ClearedWick Electrode, Model M019260
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Hearing Systems · GXY Electrode, Cutaneous
Cleared on Dec 11, 2006 as substantially equivalent to K944314 (Bio-Logic Systems Corp., 1996) after a 32-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 11, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944314 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK944314 Disposable TM-E Cochgtrode - BLSC Part NO. 101123Bio-Logic Systems Corp. · 1996
- This deviceK063402 Wick Electrode, Model M019260Intelligent Hearing Systems · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944314 | Disposable TM-E Cochgtrode - BLSC Part NO. 101123 | Bio-Logic Systems Corp. | 1996 | — |
| 0 (this device) | K063402 | Wick Electrode, Model M019260 | Intelligent Hearing Systems | 2006 | — |
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 |
|---|---|---|---|
| * | K944314 | Disposable TM-E Cochgtrode - BLSC Part NO. 101123Summary page 1…ctrode (per CFR 882.1320) Classification Product Code: GXY Regulatory Class: Class II Predicate Device: Bio-Logic TM-ECochGtrode (K9443 14) Device Description: IHS TM-Wick Electrodes are non-invasive, cutaneous devices… | 1996 |
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?
- Its one ancestor has no recall.
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 IHS TM-Wick Electrode is intended for non-invasive use in acquiring electrocochleography (ECochG) data on patients of all ages, for the purpose of monitoring and recording in the diagnosis of cochlear and auditory disorders. The electrodes are biocompatible, non-sterile, single patient use, disposable devices. The IHS TM-Wick Electrode is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or…
Read the full statement (140 words)
The IHS TM-Wick Electrode is intended for non-invasive use in acquiring electrocochleography (ECochG) data on patients of all ages, for the purpose of monitoring and recording in the diagnosis of cochlear and auditory disorders. The electrodes are biocompatible, non-sterile, single patient use, disposable devices.
The IHS TM-Wick Electrode is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.
The anatomical sites of contact of the IHS TM-Wick Electrode for ECochG testing are the patient's ear canal and tympanic membrane (with the contact objects being a thin, soft, flexible silicone tubing and a cotton wick tip which is pre-soaked in a conductive gel/saline solution).
These electrodes will include the precaution statement: Federal law restricts this device to sale by or on the order of a physician. Single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063402: Wick Electrode, Model M019260.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063402
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