# K220196: Steth IO Spot

- Pathway: 510(k) (Traditional)
- Applicant: Stratoscientific
- Decided: Mar 24, 2022 after 59 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: 9 generations back to K952882 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200776: Eko CORE, Eko Devices, Inc. (2020) Summary page 4.

## Indications for use
The Steth IO Spot is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data, whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Steth IO Spot is intended for use on individuals undergoing physical examination. The Steth IO Spot is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis or emergency use. OTC use: Steth IO Spot can be used by a patient to be examined during a video call and to submit a non-emergent-examination for review by their healthcare provider. Rx-only use: Steth IO Spot may be prescribed by a licensed medical provider to monitor medical conditions that require the use of a stethoscope.

Source page: https://510kreport.com/device/K220196
Methodology: https://510kreport.com/methodology