# K150782: AbStats Gateway

- Pathway: 510(k) (Traditional)
- Applicant: Gi Logic, Inc.
- Decided: Dec 14, 2015 after 264 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: 7 generations back to K952882 (1996). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132560: PCP-Usb Stethoscope, Rnk Products, Inc. (2013) Summary page 4.

## Most influential descendants
- K211068: PrevisEA Device (2021), 1 descendant of its own
- K230769: PrevisEA Device (2023), 0 descendants of its own

## Indications for use
The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system. The AbStats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. This device should be used under the direction of a licensed healthcare practitioner when it is required to determine this patient digestive state. The device has not been tested for and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K150782
Methodology: https://510kreport.com/methodology