# K173868: Serenity Body Position Sensor, Serenity RIP Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: Jul 2, 2018 after 194 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K915494 (1993). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142774: Polysmith Sleep System, Neurotronics, Inc. (2015) Summary page 5.

## Most influential descendants
- K251480: PV01 PVDF Effort Sensor (2025), 0 descendants of its own

## Indications for use
The Serenity RIP and Serenity Body Position Sensors are intended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders. The Serenity RIP and Serenity Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional. The Serenity RIP and Serenity Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of: • an alarm or alarm system; • an apnea monitor or apnea monitoring system; or • life monitor or life monitoring system.

Source page: https://510kreport.com/device/K173868
Methodology: https://510kreport.com/methodology