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Neuroreader

by Artronics

510(k) K950986

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950986 Date9 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HCS
Device Class
Class II
Regulation
21 CFR Part 882.1570
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neuroreader is a powered temperature measurement device intended for direct contact use in neurological applications. It provides temperature readings and is classified as a Class II medical device.

The device received traditional FDA 510(k) clearance (K950986) on 9 Nov 1995 and is assigned product code HCS. It is supplied by Artronics and is regulated as a Class II device under the FDA’s 882.1570 regulation.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the Neuroreader serve?

    The Neuroreader provides direct‑contact temperature readings in neurological settings, allowing clinicians to monitor patient brain or head temperature accurately during procedures or intensive care. Precise temperature data helps guide treatment decisions and detect abnormal thermal changes that could affect neurological outcomes.

  • Is the Neuroreader a single‑use device or can it be reused?

    The Neuroreader is a powered, reusable instrument. It is designed for repeated use after proper cleaning and maintenance according to the manufacturer’s instructions. Because it does not contain disposable components, clinicians can employ it across multiple patients while ensuring it remains functional and safe.

  • What are the sterility and storage requirements for the Neuroreader?

    The device itself is not supplied sterile; it must be cleaned and disinfected before each use according to standard neurology practice. After cleaning, it should be stored in a dry, temperature‑controlled environment to protect the electronics and sensor surface from moisture or extreme temperatures that could impair performance.

  • How is the Neuroreader classified and regulated by the FDA?

    The Neuroreader is classified as a Class II medical device under FDA regulation 882.1570, which covers powered temperature measurement devices for direct contact use. It received traditional 510(k) clearance (K950986) on 9 Nov 1995, indicating it is substantially equivalent to a legally marketed predicate device.