# K062943: Polysmith Sleep System, Model NTI5498

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: May 9, 2007 after 223 days
- Product code: OLZ (Automatic Event Detection Software For 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: 2 generations back to K862527 (1986). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022121: PSG Input Box, Model JE-912AK, Nihon Kohden America, Inc. (2002) Summary page 1.
- K971803: Neurotronics Polysomnography System 101, Neurotronics, Inc. (1997) Summary page 1.

## Most influential descendants
- K120888: PSG-1100 Sleep Diagnostic System (2012), 6 descendants of its own
- K142774: Polysmith Sleep System (2015), 4 descendants of its own
- 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

## 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. This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system. This 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. This device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

Source page: https://510kreport.com/device/K062943
Methodology: https://510kreport.com/methodology