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Accessory to Clinical Electronic Thermometer

by Sheridan Catheter Corp.

510(k) K890823

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890823 Date5 May 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is an accessory designed to complement a clinical electronic thermometer, as classified under product code FLL. It is intended for use in conjunction with electronic temperature measurement systems to enhance accuracy, reliability, or functionality in clinical settings. The accessory supports the core function of electronic thermometry by ensuring proper interfacing or calibration between the thermometer probe and monitoring equipment.

The accessory is supplied as a single-use or reusable component, depending on its specific design and intended use case, though this is not explicitly detailed in the provided data. It is regulated under FDA 510(k) clearance (K890823) and falls under the General Hospital advisory committee category. No additional details regarding sterility, MRI safety, or storage conditions are specified in the available records. The device was cleared for market under the Traditional 510(k) pathway in 1989.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the purpose of this accessory for a clinical electronic thermometer?

    This accessory is designed to improve the performance of electronic thermometers by ensuring proper interfacing or calibration between the probe and monitoring equipment. It helps enhance accuracy, reliability, or functionality in clinical settings where precise temperature measurements are critical.

  • Is this accessory single-use or reusable?

    The provided data does not specify whether this accessory is single-use or reusable. The design and intended use case would determine its suitability for reuse, but no explicit details are available in the records.

  • What regulatory pathway was used for FDA clearance of this device?

    This accessory was cleared for market under the Traditional 510(k) pathway by the FDA in 1989. It was classified under product code FLL and falls under the General Hospital advisory committee category, with clearance number K890823.

  • Does this accessory require any special storage conditions?

    The available records do not provide specific details regarding storage conditions for this accessory. Standard environmental controls for medical devices should be followed unless manufacturer guidelines specify otherwise.

  • Is sterility information provided for this accessory?

    No, the provided data does not include any details about sterility for this accessory. Sterility would depend on its intended use (single-use or reusable) and any applicable manufacturing or packaging standards.