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MD Monitoring/Diagnostic Electrode (K870873)

by Lectec Corp.

510(k) K870873

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 NumberK870873 Date10 Apr 1987ClearedStatusActive

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  • Withdrawn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
Md Monitoring/Diagnostic Electrode
510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 MD Monitoring/Diagnostic Electrode (K870873) is a reusable adhesive electrode designed for cardiovascular monitoring and diagnostic purposes. It facilitates the attachment of monitoring leads to the patient’s skin, enabling accurate electrocardiogram (ECG) signal acquisition for real-time cardiac assessment.

This device is supplied sterile and intended for single-use applications in clinical settings, including hospitals and diagnostic centers. It is classified under FDA product code DRX and has received a Traditional 510(k) clearance under the Cardiovascular advisory committee. Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.

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