# K073269: HC1000P Sleep Diagnosis Software System

- Pathway: 510(k) (Traditional)
- Applicant: Hypnocore, Ltd.
- Decided: Apr 18, 2008 after 149 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: 5 generations back to K913396 (1992). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041904: Compass F10 System, Medcare Flaga (2004)
- K070326: Noga Automated Sleep Study Scoring and Data Management System, Widemed, Ltd. (2007) Summary page 1.

## Indications for use
HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.

Source page: https://510kreport.com/device/K073269
Methodology: https://510kreport.com/methodology