# K022540: Cardio ID+(RZ153+)

- Pathway: 510(k) (Traditional)
- Applicant: Rozinn Electronics, Inc.
- Decided: Oct 24, 2002 after 84 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001288 (2000). 1 ancestor in all.
59 later devices descend from it; 6 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001288: DR180-II, North East Monitoring, Inc. (2000)

## Most influential descendants
- K032466: Spiderview (2003), 56 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
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own

## Indications for use
Detection of Arrhythmia. The Rozinn 153+ is indicated for use in continuous monitoring of Cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ is indicated for use to determine whether current pharmacological treatment (s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. Pacemaker evaluation is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician

Source page: https://510kreport.com/device/K022540
Methodology: https://510kreport.com/methodology