Cleared Abbreviated

K983626 - KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

K983626 is an FDA 510(k) clearance for KING OF HEARTS EXPRESS II & KING OF HEA..., manufactured by Alaris Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Abbreviated 510(k) pathway after a 113-day FDA review.

K983626 · Alaris Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
113d
Days
Class 2
Risk

K983626 is an FDA 510(k) clearance for the KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (Hillsboro, US). The FDA issued a Cleared decision on February 5, 1999 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K983626

510(k) Number K983626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date February 05, 1999
Days to Decision 113 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Standards-based clearance path.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 239
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K983626.
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PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
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FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
K982228 · Tz Medical, Inc. · Jan 1999
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026 · Card Guard Scientific Survival , Ltd. · Dec 1998
K983626 · KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
Download PDF FDA Summary Alaris Medical System…