# K022121: PSG Input Box, Model JE-912AK

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jul 29, 2002 after 28 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: 1 generation back to K011204 (2001). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011204: Neurofax, Models Eeg-1100A, Eeg-9100A, Nihon Kohden America, Inc. (2001) Summary page 1.

## Most influential descendants
- K062943: Polysmith Sleep System, Model NTI5498 (2007), 7 descendants of its own
- K050833: Electrode Junction Box, Model JE-921A (2005), 7 descendants of its own
- 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

## Indications for use
The device is intended to record cerebral, extracerebral and other bio-potential activities for EEG and Sleep Studies via legally marketed PSG reading software. These data may be used by clinicians in sleep disorders, Epilepsies and other related disorders as a diagnostic aid. The device is intended for use by medical personnel in any location within a medical facility, physician’s office, laboratory, clinic or nursing heme or outside of a medical facility under direct supervision of a medical professional. The device will be available on ail patient populations (including adults and children) as determined by a trained professional.

Source page: https://510kreport.com/device/K022121
Methodology: https://510kreport.com/methodology