# K243603: AeviceMD

- Pathway: 510(k) (Traditional)
- Applicant: Aevice Health Pte., Ltd.
- Decided: May 5, 2025 after 165 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K943862 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223382: AeviceMD, Aevice Health Pte., Ltd. (2023) Summary page 5.

## Indications for use
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

Source page: https://510kreport.com/device/K243603
Methodology: https://510kreport.com/methodology