# K072014: Vitascore

- Pathway: 510(k) (Traditional)
- Applicant: Vitascore B.V.
- Decided: Nov 8, 2007 after 108 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: 2 generations back to K873535 (1987). 3 ancestors in all.
40 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955841: Sleep System for Clinics & Research, Compumedics Ptd, Ltd. (1997) Summary page 1.

## Most influential descendants
- K082968: Apneicare Connection Center/Internet Analysis (2009), 39 descendants of its own
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own
- K120447: X4 (2012), 18 descendants of its own
- K130013: X4 System (2013), 17 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own

## Indications for use
The Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders. The Vitascore software is intended to be used for analysis (semi-automatic and manual re-scoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. Vitascore is to be used under supervision of a physician.

Source page: https://510kreport.com/device/K072014
Methodology: https://510kreport.com/methodology