# K201077: Strados Remote Electronic Stethoscope Platform (RESP)

- Pathway: 510(k) (Traditional)
- Applicant: Strados Labs
- Decided: Dec 20, 2020 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: 6 generations back to K943862 (1995). 12 ancestors in all.
3 later devices descend 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)
- K110525: Vitalograph Model 7100 - Vitalojak, Vitalograph (Ireland), Ltd. (2011) Summary page 4.

## Most influential descendants
- K220893: Strados Remote Electronic Stethoscope Platform (RESP) (2022), 2 descendants of its own
- K223382: AeviceMD (2023), 1 descendant of its own
- K243603: AeviceMD (2025), 0 descendants of its own

## Indications for use
The RESP 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 healthcare setting. The device stores the data for later playback, review, and analysis by a clinician on a mobile app.

Source page: https://510kreport.com/device/K201077
Methodology: https://510kreport.com/methodology