# K221805: AccurSound Electronic Stethoscope AS-101

- Pathway: 510(k) (Traditional)
- Applicant: Heroic Faith International, Ltd.
- Decided: Mar 23, 2023 after 274 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: 5 generations back to K771653 (1977). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 4.

## Most influential descendants
- K242971: AccurSound Electronic Stethoscope (AS101) (2024), 1 descendant of its own
- K243183: RTMsense Respiratory Monitoring System (2025), 0 descendants of its own

## Indications for use
The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.

Source page: https://510kreport.com/device/K221805
Methodology: https://510kreport.com/methodology