# K162503: Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Insight, Inc.
- Decided: Mar 24, 2017 after 198 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: 7 generations back to K963725 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 4.

## Indications for use
The Stealth System S300 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 or who are at risk of developing atrial fibrillation and where a software-assisted analysis of an ambulatory ECG could identify potential cardiac causes of these symptoms. It includes a prescription only, single use, continuous ECG recorder that can be worn up to 7 days during activities of daily living.

Source page: https://510kreport.com/device/K162503
Methodology: https://510kreport.com/methodology