# K961937: Simulscope Auscultation and Simulscope Bedside Auscultation System

- Pathway: 510(k) (Traditional)
- Applicant: Delphi Consulting Group
- Decided: Dec 9, 1996 after 203 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
No predicates in its family tree.
52 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Graphic Auscultation System: named in the summary without a submission number
- (no number) DEP-200 Digital Stethoscope: named in the summary without a submission number

## Most influential descendants
- K991367: Meditron Stethoscope System (1999), 51 descendants of its own
- K072026: RNK Electronic Stethoscope (2007), 29 descendants of its own
- K102893: PCP/PC Stethoscope (2011), 26 descendants of its own
- K160401: Tyto Stethoscope (2016), 21 descendants of its own
- K181612: Tyto Stethoscope (OTC) (2018), 19 descendants of its own

## Indications for use
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.

Source page: https://510kreport.com/device/K961937
Methodology: https://510kreport.com/methodology