510(k) · Cleared

Cleared

PSG Input Box, Model JE-912AK

K022121510(k) SpecialCleared Jul 29, 200228-day reviewClass II21 CFR 882.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nihon Kohden America, Inc. · OLV Standard Polysomnograph With Electroencephalograph

Cleared on Jul 29, 2002 as substantially equivalent to K011204 (Nihon Kohden America, Inc., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 9 later devices descend from it.

Decided: Jul 29, 2002
Review: 28 days
Class: Class II
Product code: OLV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011204 (2001). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK011204 Neurofax, Models Eeg-1100A, Eeg-9100ANihon Kohden America, Inc. · 2001
This deviceK022121 PSG Input Box, Model JE-912AKNihon Kohden America, Inc. · 2002
Descendant · cites it directly · 7 of its ownK062943 Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007
Descendant · cites it directly · 7 of its ownK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
Descendant · cites it directly · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
Descendant · 2 generations on · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
Descendant · 3 generations on · 1 of its ownK173868 Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005high 2 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 9 · See all

K062943Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007 · cites it directly7descendants
K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005 · cites it directly7descendants
K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · cites it directly6descendants
K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 2 generations on4descendants
K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011204	Neurofax, Models Eeg-1100A, Eeg-9100A	Nihon Kohden America, Inc.	2001	—
0 (this device)	K022121	PSG Input Box, Model JE-912AK	Nihon Kohden America, Inc.	2002	—
+1	K062943	Polysmith Sleep System, Model NTI5498	Neurotronics, Inc.	2007	—
+1	K050833	Electrode Junction Box, Model JE-921A	Nihon Kohden America, Inc.	2005	—
+1	K120888	PSG-1100 Sleep Diagnostic System	Nihon Kohden Corp.	2012	1
+2	K142774	Polysmith Sleep System	Neurotronics, Inc.	2015	—
+3	K173868	Serenity Body Position Sensor, Serenity RIP Sensors	Neurotronics, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2012	1	0
2013	1	0
2015	1	0
2017	1	0
2018	2	0
2025	1	0

FIG. 1 — Lineage of K022121, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OLV device

#1 K241288 Noxturnal Webscore 17.3 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K011204	Neurofax, Models Eeg-1100A, Eeg-9100A Summary page 1 …r GWQ. Common names for the device include Electroencephalograph {EEG) and Polysomnograph (PSG). ‘Legally Marketed Predicate: Nihon Kohden EEG 9100, cleared under 510K, K011204 There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate devic…	Nihon Kohden America, Inc.	2001	—

Also cleared against K011204: 2 other devices →

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062943	Polysmith Sleep System, Model NTI5498	Neurotronics, Inc.	2007	7
K050833	Electrode Junction Box, Model JE-921A	Nihon Kohden America, Inc.	2005	7
K120888	PSG-1100 Sleep Diagnostic System	Nihon Kohden Corp.	2012	6

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K062943 (Neurotronics, Inc., 2007) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K011204.

How does its category compare?

All OLV devices

OLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLV

1in 2025

2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLV

141in 2018

2007high 141 (2018) · low 83 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLV

No recall names OLV since 2007.

Adverse event reports per year · OLV

1in 2025

2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code OLV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	2	—	0
2009	0	—	0
2010	1	—	0
2011	2	—	0
2012	0	—	0
2013	1	—	1
2014	0	—	0
2015	1	—	0
2016	0	—	4
2017	3	83	0
2018	3	141	3
2019	0	—	1
2020	2	—	0
2021	0	—	3
2022	1	—	3
2023	0	—	2
2024	2	—	2
2025	1	—	1
2026	2	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K022121 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022121: PSG Input Box, Model JE-912AK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022121

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026