510(k) · Cleared
ClearedX-trodes System M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Trodes · GWL Amplifier, Physiological Signal
Cleared on Feb 4, 2024 as substantially equivalent to K203331 (Cgx, LLC, 2021) and 2 other predicates after a 193-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Feb 4, 2024
- Review
- 193 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K903644 (1991). 56 ancestors in all, the oldest K780045 (1978). No later device cites it as a predicate yet.
- Root · 13 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 9 generations between
- 3 generations backK170995 ElectrocardiographEdan Instruments, Inc. · 2017
- 2 generations backK212278 ElectrocardiographEdan Instruments, Inc. · 2022
- 1 generation backK222902 Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. · 2023
- This deviceK232210 X-trodes System MX-Trodes · 2024
Show all 13 generations
- Root · 13 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 12 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 11 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 10 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 9 generations backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- 8 generations backK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- 7 generations backK102854 PC ECGEdan Instruments, Inc. · 2010
- 6 generations backK131819 PC ECGEdan Instruments, Inc. · 2013
- 5 generations backK152427 PC ECGEdan Instruments, Inc. · 2016
- 4 generations backK160876 PC ECGEdan Instruments, Inc. · 2017
- 3 generations backK170995 ElectrocardiographEdan Instruments, Inc. · 2017
- 2 generations backK212278 ElectrocardiographEdan Instruments, Inc. · 2022
- 1 generation backK222902 Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. · 2023
- This deviceK232210 X-trodes System MX-Trodes · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −12 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −11 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −10 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −9 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| −8 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| −7 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
| −6 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| −5 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| −4 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| −3 | K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017 | — |
| −2 | K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022 | — |
| −1 | K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023 | — |
| 0 (this device) | K232210 | X-trodes System M | X-Trodes | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 GWL? 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 GWL device
- #1 K242832 NExT Station; NExT Station Advancedscore 9.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K203331 | Quick-20mSummary page 5…lass II 5. PREDICATE DEVICE INFORMATION Primary EEG/EOG Predicate Device Name: Quick-20m 510(k) Number: K203331 Manufacturer: CGX, LLC… | 2021 |
| * | K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro Cleared while this submission was under review Summary page 6…rocardiograph (SE-1200 Pro, SE- 1201 Pro) 510(k) Number: K222902 Manufacturer: Edan Instruments, Inc. EMG Predicate Device Name:… | 2023 |
| * | K102610 | Focus Emg DeviceSummary page 6…Edan Instruments, Inc. EMG Predicate Device Name: Focus EMG 510(k) Number: K102610 Manufacturer: TeleEMG, LLC The predicate devices have not been subj… | 2011 |
| † | K202174 | Digital NeuroPort Biopotential Signal Processing System | 2021 |
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 33 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 56 ancestors have a recall of any class.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232210: X-trodes System M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232210
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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