Who is the manufacturer of Ceribell Instant EEG Headcap?

Ceribell, Inc. filed the 510(k) submission for Ceribell Instant EEG Headcap (K223086).

What is the FDA product code for Ceribell Instant EEG Headcap?

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Ceribell Instant EEG Headcap?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like Ceribell Instant EEG Headcap?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ceribell Instant EEG Headcap

K223086 · Ceribell, Inc. · GXY · Mar 22, 2023 · Neurology

Device Facts

Record ID	K223086
Device Name	Ceribell Instant EEG Headcap
Applicant	Ceribell, Inc.
Product Code	GXY · Neurology
Decision Date	Mar 22, 2023
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 882.1320
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable electrode array designed for rapid EEG signal acquisition in clinical settings. It consists of an elastic spandex-blend fabric cap, an elastic chin strap, and 9 to 19 silver/silver chloride (Ag/AgCl) electrodes mounted in soft thermoplastic elastomer (TPE) holders. The device is placed on the patient's scalp; electrodes are positioned according to the International 10-20 or 10-10 systems. An integrated cable connects the headcap to an external EEG recording or monitoring device via a standard DIN 42-802 touch-proof safety socket. The device facilitates rapid setup for clinicians, enabling EEG signal collection for diagnostic or monitoring purposes. It does not perform signal processing or analysis itself; it serves as a passive interface between the patient's scalp and the recording equipment.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated against FDA guidance 'Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway'. Testing included electrical performance (AC impedance, DC offset voltage, offset instability, internal noise, bias current tolerance), shelf-life testing, and biocompatibility (cytotoxicity, sensitization, irritation/intracutaneous reactivity per ISO 10993).

Technological Characteristics

Disposable EEG electrode array. Materials: Spandex/nylon fabric cap, TPE electrode mounts, Ag/AgCl-coated photopolymer electrodes. Connectivity: Wired via DIN 42-802 touch-proof safety socket (1.5mm). Standards: ANSI/AAMI EC12, IEC 60601-1, ISO 10993-1/5/10. Dimensions: Head size range 26cm-66cm. Cable length: 0.1m-3.0m. Passive device; no software or energy source.

Indications for Use

Indicated for use in routine clinical settings for adults and children requiring rapid placement of EEG electrodes for signal acquisition.

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

Wuhan Greentek Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162)

Related Devices

K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) · Ceribell, Inc. · Oct 31, 2025
K232052 — Ceribell Instant EEG Headband · Ceribell, Inc. · Aug 8, 2023
K254033 — Ceribell Instant EEG Headset · Ceribell, Inc. · Feb 9, 2026
K171459 — Ceribell Instant EEG Headband · Ceribell, Inc. · Aug 21, 2017
K200162 — Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) · Wuhan Greentek Pty , Ltd. · Apr 21, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 21, 2023 Ceribell, Inc. Raymond Woo, PhD Chief Technical Officer 360 N Pastoria Ave Sunnyville, California 94085 Re: K223086 Trade/Device Name: Ceribell Instant EEG Headcap Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 24, 2023 Received: January 25, 2023 Dear Dr. 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 (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 located 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. {1}------------------------------------------------ ivalence determination does not mean that FDA Page 2 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). Sincerely. # Heather L. Dean -S Heather Dean, PhD 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223086 Device Name Ceribell Instant EEG Headband Indications for Use (Describe) The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@.fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This summary is being submitted in accordance with the requirements of 21 CFR 807.92. #### Applicant Information: Ceribell, Inc. 360 North Pastoria Avenue Sunnyvale, California 94085 #### Contact Person: Raymond Woo, PhD CTO Telephone: (650) 556-4349 E-mail: ray@ceribell.com #### Device Information: | Trade Name: | Ceribell Instant EEG Headcap | |----------------------|--------------------------------------| | Common Name: | Cutaneous electrode | | Classification Name: | Cutaneous electrode (21CFR 882.1320) | | Device Class: | II | | Product Code: | GXY | #### Predicate Device: K200162, Wuhan Greentek Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) #### Date Prepared: January 24, 2023 #### 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 Instant EEG Headcap is comprised of the following components: - An elastic fabric headcap - An elastic chin strap - A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes - A cable attached to the headcap to allow connection to an EEG acquisition/recording device ● #### Indications for Use: {4}------------------------------------------------ The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. ### Comparison of Intended Use and 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 | Subject Device Ceribell Instant EEG Headcap (Ceribell, Inc.) | Predicate Device Disposable EEG Electrodes, K200162 (Wuhan Greentek Pty Ltd.) | 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 | | 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. | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. | Same | | Intended Patient population | Adults and children | Adults and children | Same | | Environment of Use | Electrophysiological | Electrophysiological | Same | | Where Used | On the head | On the head | Same | | Device Description | Disposable EEG electrode array with three sizes consisting of: • Between 9 and 19 silver/silver-chloride (Ag/AgCl) electrodes • Cable to connect to an EEG recording device • A spandex fabric headcap to secure the electrodes to the patient | Disposable EEG electrode array with three models (DL, E- CAP, FLEX-CAP) consisting of: • Between 2 to 128 silver/silver- chloride (Ag/AgCl) electrodes • Cable to connect to an EEG recording device • A spandex fabric headcap to secure the electrodes to the patient | Same | | Attribute | Subject Device Ceribell Instant EEG Headcap (Ceribell, Inc.) | Predicate Device Disposable EEG Electrodes, K200162 (Wuhan Greentek Pty Ltd.) | Comparison | | Number of Electrodes | 9 -19 | 2 - 128 electrodes | Yes, the number of electrodes of the subject device falls within the possible customizable number of electrodes of the predicate device (between 2 to 128 electrodes). | | 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 Electroencephalograp hic 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 26cm - 66cm) | Various sizes (babies to large: overall head size range 26cm - 66cm) | Same | | Cap Material | Spandex blend: Black Nylon Knitted Fabric, 82% Nylon and 18% Spandex | Spandex | The biocompatibility testing and 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. | | Electrode Mounts | Soft thermoplastic elastomer (TPE) | Silicone | 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. | | Attribute | Subject Device Ceribell Instant EEG Headcap (Ceribell, Inc.) | Predicate Device Disposable EEG Electrodes, K200162 (Wuhan Greentek Pty Ltd.) | Comparison | | Electrode Material | Silver/silver-chloride- coated photopolymer base | Silver/silver chloride ink printed on PET (polyethylene terephthalate) or silver/silver chloride- plated ABS base | 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. | | Type of Connector | Touch-proof safety socket DIN 42-802 (ø1.5mm) | Touch-proof safety socket DIN42-802 (ø1.5mm) | The electrical performance testing completed met the same requirements per FDA guidance document "Cutaneous Electrodes for Recording Purposes- Performance Criteria for Safety and Performance Based Pathway," August 2020. | | Biocompatibility Requirements | 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, Irritation or Intracutaneous Reactivity) | The biocompatibility testing met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1," issued Sep 2020, for surface device with intact skin contact. | | Cable | 0.1m-3.0m integrated single cable | 0.1m-3.0m standard ribbon cable and lead wires | Both designed in conformance with AAMI/ ANSI ES60601-1:2005(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment- Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, mod). The electrical connection compliance met the same requirements per FDA guidance document "Cutaneous Electrodes for Recording Purposes- Performance Criteria for Safety and Performance Based Pathway," August 2020. | | Attribute | Subject Device Ceribell Instant EEG Headcap (Ceribell, Inc.) | Predicate Device Disposable EEG Electrodes, K200162 (Wuhan Greentek Pty Ltd.) | Comparison | | Electrical Performance Requirements | 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 EC12 • AC Impedance: < 2 kΩ (at 10 Hz) • DC Offset Voltage: < 100 mV • Combined Offset Instability and Internal Noise: < 150 μV • Bias Current Tolerance: < 100 mV | The electrical performance testing met the same requirements per 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 • IEC 60601-1 clause 8.5.2.3 • 21 CFR 898.12 | AAMI/ANSI ES60601- 1 clause 8.5.2.3 | The electrical connection compliance met the same requirements per FDA guidance document "Cutaneous Electrodes for Recording Purposes- Performance Criteria for Safety and Performance Based Pathway," August 2020. | {5}------------------------------------------------ ============================================================================================================================================================================== {6}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {7}------------------------------------------------ The results of 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. ## Performance Data: In accordance with FDA guidance document, "Cutaneous Electrodes for Recording Purposes- Performance Criteria for Safety and Performance Based Pathway", issued on August, 14, 202, the following performance data were provided to demonstrate safety and efficacy in substantial equivalence determination: - . Electrical Performance - o AC Impedance per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes - o Offset Voltage per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes - Combined offset instability and internal noise per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes - o Bias Current Voltage (DC Voltage Offset) per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes - 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 {8}------------------------------------------------ - . Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10 #### 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 or effectiveness. Therefore, the Ceribell Instant EEG Headcap is substantially equivalent to the cleared predicate device.