# K152043: Diagnostic Station DS20

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: May 6, 2016 after 288 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 116 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 118 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050686: Cardiovit at-10PLUS, Schiller AG (2005) Summary page 5.
- K063814: BP-200 Plus, Schiller AG (2007) Summary page 5.
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw, Covidien (2014) Summary page 5.
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 5.
- K130740: Nightingale Monitoring System, Zoe Medical, Inc. (2013) Summary page 5.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 5.

## Most influential descendants
- K170182: Cardiovit FT-1 (2017), 0 descendants of its own

## Indications for use
The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions. The DS20 also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight. The DS20 is intended for data collection only. It is not intended for continuous monitoring use and does not provide an alarm function. The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.

Source page: https://510kreport.com/device/K152043
Methodology: https://510kreport.com/methodology