# K963597: Silent Night I

- Pathway: 510(k) (Traditional)
- Applicant: Local Silence, Inc.
- Decided: Jan 23, 1997 after 136 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: 1 generation back to K910870 (1991). 1 ancestor in all.
97 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910870: Edentec Model 3711 Digital Recorder, Edentec Corp. (1991) Summary page 1.

## Most influential descendants
- K981034: Silent Night II (1998), 96 descendants of its own
- 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

## Indications for use
The Silent Night 1 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. The device is designed for use in home screening of adults with possible sleep disorders.

Source page: https://510kreport.com/device/K963597
Methodology: https://510kreport.com/methodology