# K981034: Silent Night II

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Solutions, Inc.
- Decided: Oct 30, 1998 after 225 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 K910870 (1991). 3 ancestors in all.
96 later devices descend from it; 2 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963597: Silent Night I, Local Silence, Inc. (1997) Summary page 1.
- K915856: Sensormedics 4000 Series Sleep System, Sensor Medics Corp. (1992) Summary page 1.

## Most influential descendants
- K000253: Silent Night V (2000), 69 descendants of its own
- K042745: Lifescreen Apnea (2005), 63 descendants of its own
- 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

## Indications for use
The Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern during sleep. The device is designed for prescription use in home screening of adults with possible sleep disorders. Information provided by the device includes the numbers of apneic and hypopneic events and the proportion of these events to the total sleep duration; and snoring levels (in decibels). The device is capable of recording four nights or up to 40 hours for an individual patient, after which time the sleep data are downloaded for provision to the prescribing physician.

Source page: https://510kreport.com/device/K981034
Methodology: https://510kreport.com/methodology