MR Conditional Cup Electrodes
Device Facts
| Record ID | K254183 |
|---|---|
| Device Name | MR Conditional Cup Electrodes |
| Applicant | Technomed Europe |
| Product Code | GXY · Neurology |
| Decision Date | May 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
Indications for Use
The MR Conditional Cup Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the Evoked Potentials (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.
Device Story
MR Conditional Cup Electrodes consist of 10mm ABS plastic cups coated with Ag/AgCl; connected to lead wires terminating in multi-pin or DIN 42802 connectors. System includes MR Unsafe extension cables (1.0-2.5m) for connection to monitoring equipment; extension cables must be disconnected before MRI. Electrodes remain on patient during MRI/CT scans. Used in hospital settings by clinicians. Non-ferromagnetic materials minimize imaging artifacts and RF-induced heating. Enables continuous EEG/EP monitoring during imaging procedures; facilitates patient safety by allowing electrode placement to remain undisturbed while disconnecting MR-unsafe components.
Clinical Evidence
No clinical data or animal studies included. Evidence consists of bench testing: electrical safety (IEC 60601-1), mechanical testing (tensile strength, extraction force), electrical performance (impedance, offset voltage, noise), biocompatibility (ISO 10993-1), and MR compatibility (ASTM standards, ISO/TS 10974 for RF/gradient heating).
Technological Characteristics
Materials: ABS (20% glass-filled), Ag/AgCl coating. Dimensions: 10mm diameter cups. Connectivity: Multi-pin or DIN 42802 touch-proof connectors. MR Conditional: 1.5T/3.0T fields, max spatial gradient 4,000 gauss/cm, SAR limits (2W/kg whole-body, 3.2W/kg head). Non-sterile, single-patient use. No software/algorithm.
Indications for Use
Indicated for adult patients (age ≥ 21) requiring EEG or EP recording, or as a ground/reference electrode. Suitable for use in MRI or CT environments under specified conditions.
Regulatory Classification
Identification
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Predicate Devices
- Technomed's Cup Electrodes (K072016)
- Natus Manufacturing Ltd. Grass® MR Conditional/CT Cup Electrodes, Single and Array (K242346)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 7, 2026
Technomed Europe
Zara Grimshaw
Senior Regulatory Affairs Specialist
Wiebachstraat 25a
Limburg, 6466
Netherlands
Re: K254183
Trade/Device Name: MR Conditional Cup Electrodes
Regulation Number: 21 CFR 882.1320
Regulation Name: Cutaneous electrode
Regulatory Class: Class II
Product Code: GXY
Dated: April 8, 2026
Received: April 8, 2026
Dear Zara Grimshaw:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254183 - Zara Grimshaw
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K254183 - Zara Grimshaw
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Sincerely,
Tushar Bansal -S
- Tushar Bansal, PhD
- Acting Assistant Director, Acute Injury Devices Team
- DHT5B: Division of Neuromodulation and Physical Medicine Devices
- OHT5: Office of Neurological and Physical Medicine Devices
- Office of Product Evaluation and Quality
- Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254183 | ? |
| Please provide the device trade name(s). | | ? |
| MR Conditional Cup Electrodes | | |
| Please provide your Indications for Use below. | | ? |
| The MR Conditional Cup Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the Evoked Potentials (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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Technomed
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# 510(k) SUMMARY
# K254183
# Technomed Europe's MR Conditional Cup Electrodes
## 1. Submitter Details
Technomed Europe,
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
Phone: +31 (0) 43 408 6868
Contact Person: Zara Grimshaw, Senior Regulatory Affairs Specialist
Email: regulatorytechnomed@welcony.com
Date Prepared: 5th May 2026
## 2. Device
Name of Device: MR Conditional Cup Electrodes
Common Name: Cup Electrodes
Classification Name: Electrode, Cutaneous (21 CFR 882.1320)
Regulatory Class: II
Product Code: GXY
## 3. Predicate Device
Primary Predicate: Technomed's Cup Electrodes, K072016
2nd Predicate Device: Natus Manufacturing Ltd. Grass® MR Conditional/CT Cup Electrodes, Single and Array, K242346
## 4. Device Description
The MR Conditional Cup Electrodes consist of a small convex plastic (ABS) disc or cup (10mm in diameter), coated with a conductive material (silver/silver chloride (Ag/AgCl)) and attached to a conductive lead wire. The lead wire terminates at the other end with either a multi-pin connector (array variant) or a molded DIN 42802 touch proof connector (single variant). An extension cable is supplied to attach the electrode lead wire to the monitoring equipment. The extension cable is labeled as "MR Unsafe" and is not intended to be in the MRI environment.
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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The MR Conditional Cup Electrodes consist of non-ferromagnetic materials to minimize artifacts on both magnetic resonance imaging (MRI) and computational tomography (CT) imaging as well as to reduce safety risks like heating effects that can cause burns.
There are two product lines available:
1. The MR Conditional Single Connect System
2. The MR Conditional Array Connect System
The MR Conditional Single Connect System consists of two components: the MR Single Electrode (Single Electrode) and the MR Unsafe Extension Cable (Extension Cable). The MR Unsafe part of the product (Extension Cable), 1.0 to 2.5m long, is included to attach the electrode to monitoring equipment. The Extension Cable is clearly labeled with "MR Unsafe" symbols on both ends and is not intended to be used in the MR environment. This enables users to disconnect the MR Unsafe Extension Cables and leave the MR Conditional Single Electrodes (Single Electrodes) in place on the patient for MRI procedures. Up to 40 Single Electrodes can be used simultaneously on a patient.
The MR Conditional Array Connect System consists of two components: the MR Conditional Electrode Array (Electrode Array) and the MR Unsafe Extension Cable (Extension Cable). The MR Unsafe part of the product (Extension Cable), 1.0 to 2.5m long, is included to attach the Electrode Array to monitoring equipment. The Extension Cable is clearly labeled with "MR Unsafe" symbols on both ends and is not intended to be used in the MR environment. This enables users to quickly disconnect the MR Unsafe Extension Cable and leave the MR Conditional Electrode Array (Electrode Array) in place on the patient for MRI procedures. Each Electrode Array consists of up to 10 cups and up to 4 Electrode Arrays can be used simultaneously on a patient.
# 5. Indications for Use
The MRI/CT Cups are intended for use in the recording of the Electroencephalogram (EEG), the Evoked Potentials (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.
# 6. Comparison of technological characteristics with the predicate device
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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medical accessories
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| Characteristic | Subject Device MRI/CT Cups | Primary Predicate (K072016) | 2nd Predicate (K242346) | Similarities |
| --- | --- | --- | --- | --- |
| Device Name | Cup Electrode | Cup Electrode | Cutaneous Electrode | Identical to predicates |
| Classification Code | GXY | GXY | GXY | Identical to predicates |
| Classification Name | Cutaneous, Electrode | Cutaneous, Electrode | Cutaneous, Electrode | Identical to predicates |
| Regulation Number | 21 CFR 882.1320, Class II | 21 CFR 882.1320, Class II | 21 CFR 882.1320, Class II | Identical to predicates |
| Manufacturer | Technomed Europe | Technomed Europe | Natus Manufacturing Limited | Identical to primary predicate |
| Indications for Use | The MR Conditional Cup Electrodes are intended for use in Electroencephalography (EEG), the Evoked Potentials (EP), or as a ground and reference in EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions. | The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials. | The Grass® MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the Evoked Potential (EP, or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions. | Identical to 2nd predicate. Similar to primary predicate. |
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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medical accessories
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| Target Population | Adult (age ≥ 21) | All patients | 2 years and older | Equivalent to predicates – subject device has reduced target population |
| --- | --- | --- | --- | --- |
| Where Used | Hospitals | Hospitals | Hospitals | Identical to predicates |
| Duration of Use | Prolonged (>24 hours but < 30 days) | Prolonged (>24 hours but < 30 days) | Prolonged (>24 hours but < 30 days) | Identical to predicates |
| Materials | | | | |
| Electrode Material (patient contacting) | ABS 20% glass filled, AG/AgCl coated | ABS 20% glass filled, AG/AgCl coated | ABS 20% class filled, Ag/AgCl coated | Identical to predicates |
| Wire (non-patient contacting) | Conductive Carbon Fibre Cable, PVC coated | Tin plated copper lead wire | Carbon Conductive Cable, PVC coated | Equivalent in safety and effectiveness to 2ndpredicate |
| Dimensions and Configurations | | | | |
| Electrode Diameter | 10mm | 6mm or 10mm | 10mm | Identical to predicates |
| Lead Wire Length | 19.5cm (arrays) 28.2cm (singles) | Variety | 27.0cm (arrays) 28.2cm (singles) | Singles identical to 2ndpredicate. Arrays equivalent in safety and effectiveness |
| Extension Cable Length | 1m to 2.5m | N/A | Unknown | Equivalent to 2ndpredicate – does not impact safety and effectiveness |
| Configurations | Single and array | N/A | Single and array | Identical to 2ndpredicate |
| Amount of arrays | 1 to 4 | N/A | 1 to 4 | Identical to 2ndpredicate |
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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medical accessories
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| Amount of electrodes | 2 to 40 electrodes (up to 10 per array) | 36 electrodes (adult population) | 1 to 30 electrodes (5 to 9 lead wires per array) | Equivalent to predicates |
| --- | --- | --- | --- | --- |
| Compatibility and Connections | | | | |
| MR Conditions | MR Conditional in configurations of 2 to 40 electrodes, up to 10 per array. These electrodes can safely remain on a patient during an MR scan meeting the following conditions: - Static magnetic field of 1.5 and 3.0 - Max spatial field gradient 4,000 gauss/cm, - Whole-body averaged SAR of 2W/kg and whole head averaged SAR of 3.2W/kg, - Quadrature driven transmit body coil only | Not MR Conditional | MR Conditional in configurations of 1 to 30 electrodes, using 5 to 9 arrays. These electrodes can safely remain on a patient during an MR scan meeting the following conditions: - Static magnetic field of 1.5 and 3.0 Tesla - Maximum spatial field gradient of 3,000 gauss/cm [30T/m] - Maximum MR system reported whole-body averaged specific absorption rate (SAR) of 2 W/kg and whole-head averaged SAR of 3.2 W/kg | Equivalent to 2ndpredicate - does not impact safety and effectiveness |
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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| | - 60 minutes of continuous scanning under normal operating mode | | - Quadrature driven transmit body and head coil - Normal operating mode of SAR limits for 60 minutes of continuous RF | |
| --- | --- | --- | --- | --- |
| Connector | Touch proof multipin connector (arrays) and Moulded touch proof connector (DIN 42802) | Moulded touch proof connector (DIN 42802) | Touch proof multipin connector | Identical to predicates |
| Other Information | | | | |
| Max resistance | < 40 Ω (singles) < 30 Ω (arrays) | N/A | < 40 Ω (singles) <36.5 Ω (arrays) | Equivalent to 2^{nd} predicate – does not impact safety and effectiveness |
| Impedance | < 500 Ω | < 2 kΩ | < 2 kΩ | Identical to predicates |
| Shelf Life | N/A | N/A | N/A | Identical to predicates |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Identical to predicates |
| Single use | Yes | Single use and reusable variants | Yes | Identical to predicates |
## 7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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| Testing | Summary |
| --- | --- |
| Electrical Safety | The MR Conditional Cup Electrodes were verified for performance in accordance with IEC 60601-1, Clause 8.5.2.3 - Medical Electrical Equipment – Part 1: General requirements for the basic safety and essential performance. |
| Performance Testing - Bench | The MR Conditional Cup Electrodes successfully passed performance verification in accordance with internal requirements and specifications. The verification confirmed the device performed as intended and met all the defined acceptance criteria and did not raise any new concerns of safety and effectiveness. The following tests included: • Visual Inspection - Length and diameter of MR Conditional lead wire and extension cable - Length of shrink tubes - DIN42802 Guide pin measurements - Visual inspection cable, cup, shrink tube and finished product • Mechanical Testing - Wire tensile strength - Tensile strength cup to wire - Tensile strength DIN42802 to Wire - DIN42802 to 1.5mm pin extraction force (1x) - DIN42802 to 1.5mm pin extraction force after 30 mating/unmating cycles • Electrical Testing - AC impedance - Offset Voltage - Combined offset instability and internal noise - Bias Current Tolerance - Total electrical resistance of each separate electrode - Total end-to-end electrical resistance of each extension cable - Total electrical resistance of each electrode connected to extension cable |
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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medical accessories
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| Biocompatibility Testing | The biocompatibility of the MR Conditional Cup Electrodes was conducted in accordance with ISO 10993-1:2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The subject device is considered a surface device (skin) for a duration of >24 hours - ≤30 days. Biocompatibility of the subject device is confirmed. |
| --- | --- |
| MR Compatibility | The MR safety and performance of the MR Conditional Cup Electrodes was determined using the same test methodology as the predicate which included: • Worst case device configuration was established through feasibility testing • The worst-case configuration was tested to the applicable ASTM standards: - MR Image Artefact - Magnetically Induced Displacement Force - Magnetically Induced Torque • RF-Induced Heating and Gradient Induced Heating was tested according to ISO/TS 10974 The results of the MR safety and functional tests determined conditionality and labelling information for both 1.5T and 3.0T MR environments. Testing was carried out by an accredited MR testing laboratory and concluded that the MR Conditional Cup Electrodes demonstrated equivalence in terms of functionality, safety and effectiveness to the predicate device. |
Animal and Clinical studies were not included as part of this submission.
# 8. Conclusion
The results of the performance testing described above demonstrate that the MR Conditional Cup Electrodes manufactured by Technomed Europe, are as safe and effective as the predicate devices and do not raise new concerns of safety and effectiveness, supporting a determination of substantial equivalence to the
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
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Technomed
medical accessories
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predicate devices. The intended use and technology of the subject and predicate devices are equivalent.
Technomed Europe
Wiebachstraat 25a
6466 NG Kerkrade
The Netherlands
T +31 (43) 408 6868
infotechnomed@welcony.com
www.technomedmedical.com
Chamber of Commerce Reg.nr. 14049781
IBAN nr.: NL80ABNA0441485987
Vat-nr.: NL803379936B01
