# K070550: Ausco ES-3100

- Pathway: 510(k) (Traditional)
- Applicant: Koratek Company, Ltd.
- Decided: Nov 6, 2007 after 252 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: 3 generations back to K771653 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041934: 3M Littmann Electronic Stethoscope, Model 3000, 3M Company (2004) Summary page 1.
- K961848: 3M Littmann Electronic Stethoscope, Minnesota Mining and Mfg. Co. (1997) Summary page 1.
- K012304: Adc 656 Electronic Stethoscope, American Diagnostic Corp. (2001) Summary page 1.

## Indications for use
The AUSCO ES-3100 Electronic Stethoscope is intended for medical diagnostic purposes. It may be used for the 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.

Source page: https://510kreport.com/device/K070550
Methodology: https://510kreport.com/methodology