# K000396: Apnoescreen Pro, Alpha Screen Pro

- Pathway: 510(k) (Traditional)
- Applicant: Erich Jaeger, Inc.
- Decided: Dec 27, 2000 after 324 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
No predicates in its family tree.
18 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021138: Sleepscreen/Apnoescreen Cardio (2003), 17 descendants of its own
- 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

Source page: https://510kreport.com/device/K000396
Methodology: https://510kreport.com/methodology