Skip to content

King of Hearts

by Instromedix, Inc.

510(k) K880626

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 NumberK880626 Date11 Apr 1988ClearedStatusActive

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  • Withdrawn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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 a transmitter and receiver for electrocardiograph telephone systems, classified under the cardiovascular medical specialty. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

Manufactured by Instromedix, Inc., the device received FDA 510(k) clearance under K880626 on April 11, 1988, following submission on February 16, 1988. It is associated with product code DXH and regulation number 870.2920, and is registered under multiple facility establishment identifiers.

Other devices from Instromedix, Inc.

See all devices from Instromedix, Inc. →

Questions

AI-generated answers, 23 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 KING OF HEARTS device used for?

    The KING OF HEARTS is a transmitter and receiver designed for electrocardiograph telephone systems, enabling remote transmission of ECG signals over telephone lines for cardiovascular monitoring and diagnostic support.

  • Who manufactures the KING OF HEARTS device and when was it cleared?

    The KING OF HEARTS is manufactured by Instromedix, Inc. and received FDA 510(k) clearance under submission K880626 on April 11, 1988, following an initial submission on February 16, 1988.

  • What regulatory pathway and classification apply to the KING OF HEARTS?

    The KING OF HEARTS was cleared through the traditional 510(k) pathway as a substantially equivalent device, classified as a Class II medical device under product code DXH and regulation number 870.2920 in the cardiovascular specialty.