← Back to catalogue

Vitaport 3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000338

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K000338 FDA 510(k)
FDA Product Code
OLV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1400 FDA 510(k)
Regulation Number
882.1400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vitaport 3 is a Standard Polysomnograph with Electroencephalograph, a Class II medical device designed for the recording and analysis of physiological signals during sleep studies. It integrates electroencephalography (EEG) with other polysomnographic parameters to monitor brain activity, respiration, heart rate, and other vital signs for diagnostic purposes in neurology.

This device is intended for use in clinical sleep laboratories and is supplied as a reusable system with disposable accessories. It has been cleared by the FDA under 510(k) K000338, adhering to regulation number 882.1400. The Vitaport 3 operates in non-MRI environments and requires proper calibration and maintenance as specified in its technical documentation. No sterility claims are made, and its use is governed by regulatory standards for polysomnographic equipment.

Frequently asked questions

What types of physiological signals can the Vitaport 3 monitor during sleep studies, and how does it integrate these signals for diagnostic purposes?

The Vitaport 3 is designed to record and analyze multiple physiological signals during sleep studies, including brain activity via electroencephalography (EEG), respiration, heart rate, and other vital signs. It integrates these parameters into a comprehensive polysomnographic assessment, enabling clinicians to diagnose sleep-related disorders in neurology by correlating brain activity with respiratory and cardiac data.

Is the Vitaport 3 system reusable, and if so, what are the key considerations for its maintenance and calibration?

Yes, the Vitaport 3 is supplied as a reusable system, but it requires proper calibration and maintenance as outlined in its technical documentation. Since it is not sterile, it must be cleaned and serviced according to manufacturer guidelines to ensure accurate and reliable performance for repeated use in clinical sleep laboratories.

Can the Vitaport 3 be used in an MRI environment, and if not, what are the operational limitations?

No, the Vitaport 3 is not designed for MRI environments. Its use is explicitly restricted to non-MRI settings, meaning it should only be operated in areas where MRI equipment is not present to avoid interference or safety risks.

What regulatory pathway was followed for FDA clearance of the Vitaport 3, and what does this mean for its intended use?

The Vitaport 3 was cleared via the traditional 510(k) pathway (K000338), determined to be substantially equivalent to a predicate device under FDA regulation 882.1400. This clearance confirms its compliance with U.S. standards for Standard Polysomnographs with Electroencephalography, ensuring it meets safety and performance requirements for clinical sleep studies in neurology.

Are there specific model variations or configurations available for the Vitaport 3, and how might they differ?

While the provided data lists multiple registration numbers (e.g., 3011120183, 3007616088), these correspond to product variations or lot-specific identifiers rather than distinct clinical models. The core functionality remains consistent across configurations, focusing on polysomnographic recording with EEG, though specific accessories or software updates may vary. For precise model differences, refer to the manufacturer’s documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vitaport 3 510 (k) FDA Premarket Notification K000338 NIHON KOHDEN ..., Nihon Kohden Home, Supplies & Accessories - NIHON KOHDEN GLOBAL, Class 2 Device Recall Nihon Kohden Adult/Pediatric Forehead Disposable ..., Nihon Kohden Corporation FDA 510 (k) Products - Latest 2026

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K000338 24 fields · synced Sep 19, 2026