510(k) · Cleared
ClearedNeuroCap (Model DEC22)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memory MD, Inc. · GXY Electrode, Cutaneous
Cleared on Mar 5, 2021 as substantially equivalent to K172866 (Memory MD, Inc., 2018) and 1 other predicate after a 157-day review. Its family tree reaches back 5 generations to 1978.
- Decided
- Mar 5, 2021
- Review
- 157 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K780045 (1978). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 4 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 3 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 2 generations backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- 1 generation backK162460 WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsWavi Co. · 2017
- This deviceK202913 NeuroCap (Model DEC22)Memory MD, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −4 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −3 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −2 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| −1 | K162460 | WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts | Wavi Co. | 2017 | — |
| 0 (this device) | K202913 | NeuroCap (Model DEC22) | Memory MD, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K172866 | NeuroCapSummary page 4…me: DEC22 Product Code: GXY Regulation Number: 882.1320 Regulatory Class: II Review Panel: Neurology 3. Predicate Device Information Predicate Device 1: 510(K) Number: K172866 Company Name: Memory MD INC Common Name: Cutaneous electrode Classification Name: Electrode, Cutaneous Trade Name: NeuroCap Model… | 2018 |
| * | K162460 | WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsSummary page 5…de: GXY Page 1 of 5 Predicate Device 2: 510(K) Number: K162460 Company Name: WAVi Co. Common Name: Cutaneous electrode Classification Name: Electrode, Cutaneous Trade Contacts Model: WH-100: X… | 2017 |
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 43 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 NeuroCap (Model DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202913: NeuroCap (Model DEC22).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202913
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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