# K230769: PrevisEA Device

- Pathway: 510(k) (Traditional)
- Applicant: Entac Medical, Inc.
- Decided: May 19, 2023 after 60 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211068: PrevisEA Device, Entac Medical, Inc. (2021) Summary page 4.

## Indications for use
PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K230769
Methodology: https://510kreport.com/methodology