# K123148: Parace MD Ekoscope IS100

- Pathway: 510(k) (Traditional)
- Applicant: Parace, LLC
- Decided: Nov 19, 2013 after 410 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051790: 3M Littmann Electronic Stethoscope, Model 4100, 3M Company (2005) Summary page 1.
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 1.
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200, Edan Instruments, Inc. (2009) Summary page 1.

## Indications for use
The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (EGG) function with three modes of operation. The Belle mode processes sounds having a frequency range of 20H-z to 5001-z. Secondly the Diaphragm made processes sound within a range of 20 Hz to 700 H~z. The third mode is the Diaphragm plus mode. The Diaphragm plus mode processes mechanical heart sounds between 1KHz to 20KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other Internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.. The EGG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The EGG are detectable by a series of electrodes markced as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and rhythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE Is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is Intended for use In hospitals or healthcare facilities by doctors and trained health care professionals. Caution: Federal Law restricts this device to sale by or on the order of a licensed health care practitioner.

Source page: https://510kreport.com/device/K123148
Methodology: https://510kreport.com/methodology