# K252915: AiSteth®

- Pathway: 510(k) (Traditional)
- Applicant: Ai Health Highway India Pvt., Ltd.
- Decided: May 22, 2026 after 252 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: 1 generation back to K151319 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151319: Eko Electronic Stethoscope System, Eko Devices, Inc. (2015) Summary page 6.

## Indications for use
The AiSteth® Platform (AiSteth® Device + Mobile applications on Android & iOS) is intended to be used as part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. AiSteth® is intended for use on pediatric and adult patients. It can record, store, amplify, filter and share sounds on the accompanying mobile applications for storage and sharing. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

Source page: https://510kreport.com/device/K252915
Methodology: https://510kreport.com/methodology