# K991367: Meditron Stethoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Meditron AS
- Decided: Jul 19, 1999 after 90 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: 2 generations back to K771653 (1977). 5 ancestors in all.
51 later devices descend from it; 6 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961301: E-Scope Electronic Stethoscope Model 718-7120, Delphi Consulting Group (1996) Summary page 1.
- K963621: Stethos, Theratechnologies, Inc. (1996) Summary page 1.
- K961937: Simulscope Auscultation and Simulscope Bedside Auscultation System, Delphi Consulting Group (1996) Summary page 1.
- K961857: Labtron Electromax Electronic Stethoscope Model NO. 04-1060, Graham-Field, Inc. (1996). Our OCR of the scanned summary read K961837, FDA’s number for Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy (Rusch Intl.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Labtron Electromax Electronic Stethoscope Model N”.

## Most influential descendants
- 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
- K013725: Meditron II Thesterthoscope System (2002), 16 descendants of its own

## Indications for use
The Meditron Stethoscope System is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies sounds from the bodys internal organs, mainly the heart and respitatory and circulatory omgans. It provides computer-aided recordings of these sounds and stores these recordings along with other appropriate patient information.

Source page: https://510kreport.com/device/K991367
Methodology: https://510kreport.com/methodology