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Pregelled Infant Disposable ECG Electrode

by Labeltape Meditect, Inc.

510(k) K862756

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 NumberK862756 Date6 Aug 1986ClearedStatusActive

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  • Withdrawn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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
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.

A pregelled infant disposable ECG electrode is a medical device designed for electrocardiographic monitoring in infant patients. It features a conductive gel pre-applied to the electrode surface to ensure reliable electrical contact with the skin during use.

This device is supplied as a single-use, sterile product intended for use in clinical settings such as hospitals or outpatient facilities. It is not MRI safe unless specifically labeled as such, and it should be stored according to manufacturer instructions. The device received FDA 510(k) clearance under K862756 on August 6, 1986, and is classified under product code DXN with cardiovascular advisory committee review.

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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 is the PREGELLED INFANT DISPOSABLE ECG ELECTRODE used for?

    It is designed for electrocardiographic monitoring in infant patients, providing reliable electrical contact with the skin through its pre-applied conductive gel during ECG procedures in clinical settings such as hospitals or outpatient facilities.

  • How is the PREGELLED INFANT DISPOSABLE ECG ELECTRODE supplied and is it reusable?

    The device is supplied as a single-use, sterile product, meaning each electrode is intended for one patient only and must be discarded after use to prevent cross-contamination and ensure optimal gel conductivity and adhesion.

  • What regulatory pathway was used for the PREGELLED INFANT DISPOSABLE ECG ELECTRODE and what is its product code?

    The device received FDA 510(k) clearance under K862756 on August 6, 1986, and is classified under product code DXN, with cardiovascular advisory committee review, indicating it was found substantially equivalent to a legally marketed predicate device.