# K142468: Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Insight, Inc.
- Decided: Jul 11, 2015 after 311 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: 6 generations back to K963725 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042782: Seer MC, Ge Medical Systems Information Technologies (2005) Summary page 4.
- K142743: AliveCor Heart Monitor, AliveCor, Inc. (2015). Cleared while this submission was under review Summary page 4.
- K130288: Stealth Monitor, Stealth Docking Cable, Stealth Display and Storage Device, Cardiac Insight, Inc. (2013) Summary page 4.

## Indications for use
The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, pre-syncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.

Source page: https://510kreport.com/device/K142468
Methodology: https://510kreport.com/methodology