# K142774: Polysmith Sleep System

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: Feb 18, 2015 after 145 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: 6 generations back to K915494 (1993). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062943: Polysmith Sleep System, Model NTI5498, Neurotronics, Inc. (2007) Summary page 5.
- K120888: PSG-1100 Sleep Diagnostic System, Nihon Kohden Corp. (2012) Summary page 5.

## Most influential descendants
- K173868: Serenity Body Position Sensor, Serenity RIP Sensors (2018), 1 descendant of its own
- K251480: PV01 PVDF Effort Sensor (2025), 0 descendants of its own
- K181709: Serenity Piezo Sensor, Serenity Thermocouple Sensor (2018), 0 descendants of its own
- K161650: Polysmith Sleep System, Model NTI7593 (2017), 0 descendants of its own

## Indications for use
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional. The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician. The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system. The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system. The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

Source page: https://510kreport.com/device/K142774
Methodology: https://510kreport.com/methodology