# K050833: Electrode Junction Box, Model JE-921A

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Apr 29, 2005 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: 4 generations back to K915494 (1993). 6 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 14 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.
- K040875: Cap-One, Model TG-920P, Nihon Kohden America, Inc. (2004) 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 acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool. As with the predicate, the information transferred to EEG will be stored, interpreted and printed with commercially software programs available with Nihon Kohden marketed products. The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics.

Source page: https://510kreport.com/device/K050833
Methodology: https://510kreport.com/methodology