# K000253: Silent Night V

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Solutions, Inc.
- Decided: Nov 16, 2000 after 294 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 K910870 (1991). 7 ancestors in all.
69 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981034: Silent Night II, Sleep Solutions, Inc. (1998) Summary page 1.
- K973920: Stardust, Respironics, Inc. (1998). Our OCR of the scanned summary read K973902, FDA’s number for Vinyl Patient Examination Gloves Powdered (Everrise Glove Products Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stardust”.
- K915856: Sensormedics 4000 Series Sleep System, Sensor Medics Corp. (1992) Summary page 1.
- (no number) EdenTrace M: named in the summary without a submission number

## Most influential descendants
- 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
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw (2014), 40 descendants of its own

## Indications for use
The Slient Night V is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The Silent Night V can score obstructive apneas, which includes mixed apneas.

Source page: https://510kreport.com/device/K000253
Methodology: https://510kreport.com/methodology