# K170928: CADence System

- Pathway: 510(k) (Traditional)
- Applicant: Aum Cardiovascular, Inc.
- Decided: Aug 3, 2017 after 127 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 CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application. CADence Software is a clinical decision support tool intended to aid a qualified clinician's analysis of normal/physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG. The device must be used in a clinical setting by trained personnel. The automated analysis of cardiac sounds by the CADence System are only significant when used in conjunction with physician oversight as well as consideration of all other relevant patient information. All relevant patient information must be taken into consideration before making a diagnosis. The CADence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician.

Source page: https://510kreport.com/device/K170928
Methodology: https://510kreport.com/methodology