# K120888: PSG-1100 Sleep Diagnostic System

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden Corp.
- Decided: Nov 9, 2012 after 231 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915494 (1993). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 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.
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A, Nihon Kohden America, Inc. (2008) Summary page 6.
- K050833: Electrode Junction Box, Model JE-921A, Nihon Kohden America, Inc. (2005) Summary page 3.
- K062943: Polysmith Sleep System, Model NTI5498, Neurotronics, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K161650: Polysmith Sleep System, Model NTI7593 (2017), 0 descendants of its own

## Recalls of this device
- Dec 21, 2020 · Class II · Z-0865-2021: Medical device non-conformance to electrical safety standard (IEC 60601-1).

## Indications for use
The PSG- 1100 Sleep Diagnostic System is intended to record the physiological data required for BEG and sleep studies (Polysomnography or PSG). These data may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.

Source page: https://510kreport.com/device/K120888
Methodology: https://510kreport.com/methodology