510(k) · Cleared
ClearedPMT Truscan Surface Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmt Corp. · GXY Electrode, Cutaneous
Cleared on Dec 19, 2012 as substantially equivalent to K032278 (Ambu, Inc., 2004) after a 135-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Dec 19, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032278 (2004). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K171102Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032278 | Ambu Neuroline Single Patient Eeg/EP Cup Electrode | Ambu, Inc. | 2004 | — |
| 0 (this device) | K122376 | PMT Truscan Surface Electrode | Pmt Corp. | 2012 | — |
| +1 | K171102 | Ives MR Conditional Cup Electrode | Ives Egg Solutions | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K032278 | Ambu Neuroline Single Patient Eeg/EP Cup Electrode | 2004 |
| * | — | Grass Instruments Named without a submission number |
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 |
|---|---|---|---|
| K171102 | Ives MR Conditional Cup Electrode | 2017 | 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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP). The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions: Static magnetic field strength of 1.5-T only Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less The connector hub must be placed near the center MR system's…
Read the full statement (139 words)
The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).
The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:
Static magnetic field strength of 1.5-T only
Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less
The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times.
The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan.
Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122376: PMT Truscan Surface Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122376
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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