# K223382: AeviceMD

- Pathway: 510(k) (Traditional)
- Applicant: Aevice Health Pte., Ltd.
- Decided: Jul 7, 2023 after 242 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: 8 generations back to K943862 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220893: Strados Remote Electronic Stethoscope Platform (RESP), Strados Labs, Inc. (2022) Summary page 4.

## Most influential descendants
- K243603: AeviceMD (2025), 0 descendants of its own

## 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 adult patients 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/K223382
Methodology: https://510kreport.com/methodology