# K130288: Stealth Monitor, Stealth Docking Cable, Stealth Display and Storage Device

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Insight, Inc.
- Decided: May 29, 2013 after 113 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K142468: Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System (2015), 0 descendants of its own

## Indications for use
The Stealth TM Monitor is a prescription only single use, continuous recording EG monitor that can be worn up to least 24 hours. It is indicated for use with patients where it would be desirable to record EGG signals for this period of time.

Source page: https://510kreport.com/device/K130288
Methodology: https://510kreport.com/methodology