510(k) · Cleared

Cleared

Wireless Input Unit, Model Wee-1000A Series

K033475510(k) TraditionalCleared Jan 7, 200465-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 Jan 7, 2004 as substantially equivalent to K003175 (Compumedics Limited, 2000) after a 65-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.

Decided: Jan 7, 2004
Review: 65 days
Class: Class II
Product code: OLV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003175 (2000). 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003175 Compumedics Siesta SystemCompumedics Limited · 2000
This deviceK033475 Wireless Input Unit, Model Wee-1000A SeriesNihon Kohden America, Inc. · 2004
Descendant · cites it directly · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
Descendant · 2 generations on · 1 of its ownK170441 ElectroTekMobilemedtek · 2017 · Recalled
Descendant · 2 generations on · 1 of its ownK162681 Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017
Descendant · 2 generations on · 1 of its ownK151600 R-40 EEG AmplifierLifelines, Ltd. · 2015
Descendant · 3 generations on · 0 of its ownK261604 Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio…Neuroelectrics Barcelona S.L.U. · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011high 4 (2017) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all

K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · cites it directly7descendants
K170441ElectroTekMobilemedtek · 2017 · 2 generations on1descendant
K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017 · 2 generations on1descendant
K151600R-40 EEG AmplifierLifelines, Ltd. · 2015 · 2 generations on1descendant
K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003175	Compumedics Siesta System	Compumedics Limited	2000	—
0 (this device)	K033475	Wireless Input Unit, Model Wee-1000A Series	Nihon Kohden America, Inc.	2004	—
+1	K103140	Nicolet Wireless Eeg	Carefusion 209, Inc.	2011	1
+2	K170441	ElectroTek	Mobilemedtek	2017	2
+2	K162681	Enobio Wireless EEG	Neuroelectrics Barcelona S.L.U.	2017	—
+2	K151600	R-40 EEG Amplifier	Lifelines, Ltd.	2015	—
+3	K261604	Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)	Neuroelectrics Barcelona S.L.U.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2015	1	0
2017	4	0
2018	1	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K033475, 2000–2026Source: 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
*	K003175	Compumedics Siesta System Summary page 1 …555 Fax: (949) 580-1550 Trade name: Wireless Input Unit Common Name: Electroencephalograph Classification: II : The Predicate: Siesta system by Compumedix, 510K No: K003175 The device is classified by the Neurology Panel under 21 CFR Part 882.1400 "Electroencephalograph” per GWQ7 oL The device is in…	Compumedics Limited	2000	—
†	K992742	Neurofax, Model Eeg-1100A	Nihon Kohden America, Inc.	1999	—
†	K011204	Neurofax, Models Eeg-1100A, Eeg-9100A	Nihon Kohden America, Inc.	2001	—

Also cleared against K003175: 5 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K103140	Nicolet Wireless Eeg	Carefusion 209, Inc.	2011	7
K171124	Nihon Kohden Wireless Input Unit WEE-1200	Nihon Kohden Corporation	2017	0

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, K103140 (Carefusion 209, Inc., 2011) has gone furthest, with 7 descendants of its own.
5 other devices also cite its predicate K003175.

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 acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and slecp disorders, measurement and display of cerebral and extracerebral activity for EEG and Slesp Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsics and other related disorders as a diagnostic tool, :

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.

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/K033475 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033475: Wireless Input Unit, Model Wee-1000A Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033475

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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