510(k) · Cleared
ClearedWAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavi Co. · GXY Electrode, Cutaneous
Cleared on Apr 28, 2017 as substantially equivalent to K112319 (Electro-Cap Intl., Inc., 2012) and 1 other predicate after a 238-day review. Its family tree reaches back 4 generations to 1978. 1 later device descends from it.
- Decided
- Apr 28, 2017
- Review
- 238 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K780045 (1978). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 3 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 2 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 1 generation backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- This deviceK162460 WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsWavi Co. · 2017
- Descendant · cites it directly · 0 of its ownK202913 NeuroCap (Model DEC22)Memory MD, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202913NeuroCap (Model DEC22)Memory MD, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −3 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −2 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −1 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| 0 (this device) | K162460 | WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts | Wavi Co. | 2017 | — |
| +1 | K202913 | NeuroCap (Model DEC22) | Memory MD, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K112319 | Electro-Cap SystemSummary page 4…lassification: Class II: 21 CFR § 882.1320 Classification Name: Cutaneous Electrode – GXY Predicate Devices: Electro-Cap™ System (K112319) Electro-Cap™ Intl., Inc. 1011 West Lexington Rd.… | 2012 |
| * | K780045 | Electrode CapSummary page 5…d to the Predicate: Manufacturer WAVi Co. Electro-Cap Trade Name WAVi Headset Electro-Cap System (K780045) The WAVi Headset is intended for The Electro-Cap is intended for use use in routine clin… | 1978 |
| † | K915820 | Neurosearch-24 or NRS-24 | 1995 |
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 |
|---|---|---|---|
| K202913 | NeuroCap (Model DEC22) | 2021 | 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 39 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K202913 (Memory MD, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112319.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 WAVi Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162460: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162460
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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