# K021138: Sleepscreen/Apnoescreen Cardio

- Pathway: 510(k) (Traditional)
- Applicant: Erich Jaeger GmbH
- Decided: Feb 12, 2003 after 309 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000396 (2000). 1 ancestor in all.
17 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000396: Apnoescreen Pro, Alpha Screen Pro, Erich Jaeger, Inc. (2000) Summary page 1.

## Most influential descendants
- K060708: Somnoscreen (2007), 11 descendants of its own
- K071556: Somnoscreen EEG10-20 (2007), 5 descendants of its own
- K201054: SOMNOscreen plus (2020), 4 descendants of its own
- K051907: Innocor (2006), 4 descendants of its own
- K071911: Cardiopulmonary Exercise Testing Option to Innocor (2007), 3 descendants of its own

## Indications for use
The Sleepscreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The Sleepscreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital. The Sleepscreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the Sleepscreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.

Source page: https://510kreport.com/device/K021138
Methodology: https://510kreport.com/methodology