# K983626: King of Hearts Express II & King of Hearts Express EZ II

- Pathway: 510(k) (Abbreviated)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Feb 5, 1999 after 113 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
121 later devices descend from it; 1 cites it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Instromedix King of Hearts Express 3X: named in the summary without a submission number
- (no number) Instromedix Prince: named in the summary without a submission number
- (no number) Instromedix 1200: named in the summary without a submission number
- (no number) Instromedix CarryAll: named in the summary without a submission number
- (no number) Braemar ER720: named in the summary without a submission number
- (no number) TZ Medical HeartAide Plus II: named in the summary without a submission number
- (no number) Card Guard CG-6500: named in the summary without a submission number

## Most influential descendants
- K020825: King of Hearts Express + AF Monitor (2002), 120 descendants of its own
- K052767: Afibalert Atrial Fibrillation Detector (2006), 47 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own

## Indications for use
The King of Hearts Express® II cardiac event recorder is a patient-activated device designed for diagnostic evaluation of transient symptoms such as dizziness, palpitations, syncope and chest pain. The recorder provides single lead or multiple lead ECG morphology, which may be used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena, and p-waves. The recorder may also provide automatic recording for detected bradycardia or tachycardia rhythms. The recorder may be used with pacemaker patients to assess pacemaker activity.

Source page: https://510kreport.com/device/K983626
Methodology: https://510kreport.com/methodology