# K013725: Meditron II Thesterthoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Meditron AS
- Decided: Jan 30, 2002 after 82 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). 9 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990809: Cadiscope Electronic Stethoscope, Caditec AG (1999) Summary page 1.
- K991367: Meditron Stethoscope System, Meditron AS (1999) Summary page 1.
- K953649: Disposable Ecg Electrode, Kendall-Ltp (1996) Summary page 1.

## Most influential descendants
- K110704: SENSI (2011), 13 descendants of its own
- K121617: Sensicardiac (2012), 10 descendants of its own
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application (2013), 9 descendants of its own
- K181988: eMurmur ID (2019), 7 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own

## Indications for use
Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring. It amplifies sounds from the body’s internal organs, mainly the heart and circulatory and respiratory organs. The system is includes a 3-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is nnot intended for diagnostic use. The system provides computer-aided recordings and storage of these sounds along with other patient information.

Source page: https://510kreport.com/device/K013725
Methodology: https://510kreport.com/methodology