# K042745: Lifescreen Apnea

- Pathway: 510(k) (Traditional)
- Applicant: Del Mar Reynolds Medical, Inc.
- Decided: Jan 19, 2005 after 107 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910870 (1991). 8 ancestors in all.
63 later devices descend from it; 4 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000253: Silent Night V, Sleep Solutions, Inc. (2000) Summary page 4.

## Most influential descendants
- K083325: N-600X with SPD, Oximax N-600X (2009), 53 descendants of its own
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0 (2012), 49 descendants of its own
- K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software (2012), 45 descendants of its own
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw (2014), 40 descendants of its own
- K141518: Nellcor Bedside Respiratory Patient Monitoring System (2015), 29 descendants of its own

## Recalls of this device
- Nov 11, 2011 · Not classified · Z-0520-2012: When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Bot

## Indications for use
The device is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient’s score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Source page: https://510kreport.com/device/K042745
Methodology: https://510kreport.com/methodology