# K082968: Apneicare Connection Center/Internet Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Apneicare, LLC
- Decided: Jan 2, 2009 after 88 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: 3 generations back to K873535 (1987). 5 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072014: Vitascore, Vitascore B.V. (2007) Summary page 1.
- K001708: Profox Software, Model 920M-41, Respironics Georgia, Inc. (2001)

## Most influential descendants
- 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
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (2013), 14 descendants of its own

## Indications for use
ApneiCare Connection Center/Internet Analysis is a software device, intended to be used as an aid in the diagnosis of sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis is used for analysis (semi-automatic and manual rescoring), display, redisplay (retrieve), edit, 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. ApneiCare Connection Center/Internet Analysis software also provides scoring of desaturation events as they related to sleep breathing disorders. ApneiCare Connection Center/Internet Analysis is intended to be used as an information and decision management tool to import/record and transmit/transfer data typically captured to evaluate sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician. The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

Source page: https://510kreport.com/device/K082968
Methodology: https://510kreport.com/methodology