Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION October 31, 2025 Ceribell, Inc. Raymond Woo Cto 360 North Pastoria Avenue Sunnyvale, California 94085 Re: K251381 Trade/Device Name: Ceribell Instant EEG Headcap (Small: C251, Medium: C252) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 7, 2025 Received: October 7, 2025 Dear Raymond Woo: 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" (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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251381 - Raymond Woo Page 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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). {2} K251381 - Raymond Woo Page 3 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 {3} Ceribell Instant EEG Headcap Page 8 of 35 | 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. | K251381 | ? | | Please provide the device trade name(s). | | ? | | Ceribell Instant EEG Headcap | | | | Please provide your Indications for Use below. | | ? | | The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} ceribell # 510(k) Summary – K251381 ## 1. SUBMITTER Ceribell, Inc. 360 North Pastoria Avenue Sunnyvale, California 94085 Contact Person: Raymond Woo, PhD Chief Technical Officer Telephone: (800) 436-0826 E-mail: ray@ceribell.com Alternative Contact: Angela Lynch Regulatory Affairs Manager E-mail: angela.lynch@ceribell.com Date Prepared: October 06, 2025 ## 2. DEVICE Trade Name: Ceribell Instant EEG Headcap Common Name: Cutaneous electrode Classification: Cutaneous electrode (21 CFR 882.1320) Device Class: II Product Code: GXY ## 3. PREDICATE DEVICE Ceribell Instant EEG Headcap, K223086 ## 4. DEVICE DESCRIPTION The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject’s scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device. The Ceribell Headcap includes the following components: - An elastic fabric headcap - An elastic fabric chin strap - Nine (9) silver/silver chloride (Ag/AgCl) electrodes - A cable attached to the headcap to allow connection to an EEG acquisition/recording device {5} ceribell® # 5. INDICATIONS FOR USE The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies. # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Compared to the predicate device, the subject device has the same intended use, similar product design and the same product effectiveness as the predicate device as summarized in the following table. | Attribute | Predicate Device Ceribell Instant EEG Headcap (K223086) | Subject Device Ceribell Instant EEG Headcap | Comparison | | --- | --- | --- | --- | | Classification Regulation | Class II per 21 CFR 882.1320, E Cutaneous Electrode | Class II per 21 CFR 882.1320, E Cutaneous Electrode | Same | | Product Code | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous | Same | | Intended Use | A single-use disposable headpiece with an integrated array of passive cutaneous electrodes that are applied to the patient’s head to record EEG signals when connected to an EEG recording device. | A single-use disposable headpiece with an integrated array of passive cutaneous electrodes that are applied to the patient’s head to record EEG signals when connected to an EEG recording device. | Same | | Indications for Use | The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. | The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies. | Same | {6} ceribell | Attribute | Predicate Device Ceribell Instant EEG Headcap (K223086) | Subject Device Ceribell Instant EEG Headcap | Comparison | | --- | --- | --- | --- | | Intended Patient Population | Any patient with the head size range of 26.0cm – 66.0cm | Any patient with the head size range of 26.0cm – 46.5cm | The intended patient population of the subject device falls within that of the predicate device. | | Environment of Use | Electrophysiological | Electrophysiological | Same | | Type of Patient Contact | Contacts patient’s scalp | Contacts patient’s scalp | Same | | Type of Use | Single use, non-sterile, disposable | Single use, non-sterile, disposable | Same | | Device Description | Single use, non-sterile, disposable EEG electrode array consisting of: • Silver/silver chloride (Ag/AgCl) electrodes • Integrated single-cable connector to connect an EEG recording device • A spandex blend fabric headcap to secure the electrodes to the patient | Single use, non-sterile, disposable EEG electrode array consisting of: • Silver/silver chloride (Ag/AgCl) electrodes • Integrated single-cable connector to connect an EEG recording device • A spandex blend fabric headcap to secure the electrodes to the patient | Same | | Principle of Operation | Appropriately sized headcap is fit on the patient’s head. Electrodes and chin strap are attached to the headcap. Electroconductive gel is applied to the scalp contact area, creating a conductive bridge from the scalp to the headcap electrodes. The cable of the headcap is connected to an EEG acquisition/recording device for recording of EEG signals. | Appropriately sized headcap is fit on the patient’s head. Electrodes and chin strap are attached to the headcap. Electroconductive gel is applied to the scalp contact area, creating a conductive bridge from the scalp to the headcap electrodes. The cable of the headcap is connected to an EEG acquisition/recording device for recording of EEG signals. | Same | 3 {7} ceribell | Attribute | Predicate Device Ceribell Instant EEG Headcap (K223086) | Subject Device Ceribell Instant EEG Headcap | Comparison | | --- | --- | --- | --- | | Number of Electrodes | Various configurations supporting between 9 and 19 electrodes. | Nine (9) electrodes. | The number of electrodes of the subject device falls within the possible number of electrodes of the predicate device. | | Electrode Locations | The placement of the electrodes is according to the International 10-20 system of electrode placement or the American Electroencephalographic Society positioning system (10-10). The number of the electrodes in use is according to the needs of clinical practice. | The placement of the electrodes is according to the International 10-20 system of electrode placement or the American Electroencephalographic Society positioning system (10-10). The number of the electrodes in use is according to the needs of clinical practice. | Same | | Available Sizes | Various sizes (overall head size range 26.0cm – 66.0cm) | Various sizes (overall head size range 26.0cm – 46.5cm) | The range of available sizes falls within the same range of head sizes of the predicate device. | | Cap Material | Spandex blend: Nylon Knitted Fabric, 82% Nylon and 18% Spandex | Spandex blend: Nylon Knitted Fabric, 80% Nylon and 20% Spandex | The electrical performance and biocompatibility testing completed are the same and follow the FDA guidance document “Cutaneous Electrodes for Recording Purposes-Performance Criteria for Safety and Performance Based Pathway”, August 2020. | | Electrode Mounts | Versaflex thermoplastic elastomer (TPE) | Versaflex thermoplastic elastomer (TPE) | Same | | Electrode Material | Silver/silver-chloride-coated stereolithography photopolymer base | Silver/silver-chloride on a polyethylene terephthalate (PET) flexible circuit substrate | The electrical performance and biocompatibility testing completed are the same and follow | 4 {8} ceribell | Attribute | Predicate Device Ceribell Instant EEG Headcap (K223086) | Subject Device Ceribell Instant EEG Headcap | Comparison | | --- | --- | --- | --- | | | | | the FDA guidance document “Cutaneous Electrodes for Recording Purposes-Performance Criteria for Safety and Performance Based Pathway”, August 2020. | | Biocompatibility | ISO 10993-1 ISO 10993-5 (Cytotoxicity) ISO 10993-10 (Sensitization, Irritation or Intracutaneous Reactivity) | ISO 10993-1 ISO 10993-5 (Cytotoxicity) ISO 10993-10 (Sensitization) ISO 10993-23 (Irritation or Intracutaneous Reactivity) | The biocompatibility testing completed are the same and follow the FDA guidance document “Cutaneous Electrodes for Recording Purposes-Performance Criteria for Safety and Performance Based Pathway”, August 2020. | | Cable | 0.1m – 3.0m integrated single cable | 0.1m – 3.0m integrated single cable | Same | | Electrical Performance | ANSI/AAMI EC12 • Average AC Impedance: ≤ 2 kΩ (individual pairs ≤ 3kΩ) • DC Offset Voltage: ≤ 100 mV • Combined Offset Instability and Internal Noise: ≤ 150 μV • Bias Current Tolerance: ≤ 100 mV | ANSI/AAMI EC12 • Average AC Impedance: ≤ 2 kΩ (individual pairs ≤ 3kΩ) • DC Offset Voltage: ≤ 100 mV • Combined Offset Instability and Internal Noise: ≤ 150 μV • Bias Current Tolerance: ≤ 100 mV | The electrical performance testing completed are the same and follow the FDA guidance document “Cutaneous Electrodes for Recording Purposes-Performance Criteria for Safety and Performance Based Pathway”, August 2020. | | Electrical Connection Compliance | • Conductive Connection Compliance (Patient Leads or Patient Cables) per ES 60601-1 consensus standard | • Conductive Connection Compliance (Patient Leads or Patient Cables) per ES 60601-1 consensus standard | The electrical connection compliance requirements are the same and follow the FDA guidance document “Cutaneous Electrodes for | 5 {9} ceribell® | Attribute | Predicate Device Ceribell Instant EEG Headcap (K223086) | Subject Device Ceribell Instant EEG Headcap | Comparison | | --- | --- | --- | --- | | | • IEC 60601-1 clause 8.5.2.3 • 21 CFR 898.12 | • IEC 60601-1 clause 8.5.2.3 • 21 CFR 898.12 | Recording Purposes-Performance Criteria for Safety and Performance Based Pathway", August 2020. | The results of the completed testing demonstrate that any differences in technology do not raise different questions of safety and effectiveness for the subject device compared to the predicate device. ## 7. PERFORMANCE DATA In accordance with the FDA guidance document, "Cutaneous Electrodes for Recording Purposes- Performance Criteria for Safety and Performance Based Pathway", issued on August 14, 2020, the following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination: - Electrical Performance per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes - AC Impedance - Offset Voltage - Combined offset instability and internal noise - Bias Current Voltage (DC Voltage Offset) - Shelf-Life testing per FDA-recognized consensus standards, ANSI/AAMI EC12 Disposable ECG Electrodes and IEC 60601-2-2 Medical electrical equipment- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories - Biocompatibility testing per ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23 ## 8. SUMMARY The Ceribell Instant EEG Headcap has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety and effectiveness. Therefore, the Ceribell Instant EEG Headcap is substantially equivalent to the cleared predicate device. 6