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Medi-Trace Fetal Monitoring Spiral Electrode

by Graphic Controls Corp.

510(k) K904745

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 NumberK904745 Date29 Jan 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Medi-Trace(R) Fetal Monitoring Spiral Electrode
510(k) Number
FDA Product Code
HGP
Device Class
Class II
Regulation
21 CFR Part 884.2675
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 device is an electrode, circular (spiral), scalp and applicator, used for fetal monitoring. It is a spiral electrode designed for scalp application during obstetric procedures.

It is supplied as a single-use device and has received FDA 510(k) clearance under K904745. The device is classified as Class II and is intended for use in obstetrics/gynecology settings.

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Questions

AI-generated answers, 24 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 is the MEDI-TRACE(R) Fetal Monitoring Spiral Electrode used for?

    It is used for fetal monitoring during obstetric procedures, specifically designed as a spiral electrode for scalp application to detect fetal heart rate signals.

  • Is the MEDI-TRACE(R) Fetal Monitoring Spiral Electrode reusable or single-use?

    It is supplied as a single-use device, meaning it is intended for one patient and one procedure only, then discarded to prevent cross-contamination and ensure signal integrity.

  • How is the MEDI-TRACE(R) Fetal Monitoring Spiral Electrode supplied and stored?

    It is supplied sterile and ready for use, packaged for single-use application; storage should follow standard medical device guidelines for sterile products in a clean, dry environment until use.

  • What regulatory pathway was used for the MEDI-TRACE(R) Fetal Monitoring Spiral Electrode?

    It received FDA 510(k) clearance under K904745, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as Class II for obstetrics/gynecology use.