# K230613: Skeeper

- Pathway: 510(k) (Traditional)
- Applicant: Smartsound Corporation
- Decided: Aug 2, 2023 after 149 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
Longest line of descent: 9 generations back to K952882 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200776: Eko CORE, Eko Devices, Inc. (2020) Summary page 4.

## Indications for use
SKEEPER is an electronic stethoscope that collects, filters, and amplifies the sound of a person's heart, lungs, and abdomen. It is intended for use by professional users in clinical environments or by lay users in non-clinical environments. It is not intended for self-diagnosis.

Source page: https://510kreport.com/device/K230613
Methodology: https://510kreport.com/methodology