# K022298: I-Stethos Link

- Pathway: 510(k) (Abbreviated)
- Applicant: Andromed, Inc.
- Decided: Oct 1, 2002 after 77 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute. In addition, the i-Stethos Link is equipped with an analog 1/0 port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link. The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope. The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.

Source page: https://510kreport.com/device/K022298
Methodology: https://510kreport.com/methodology