510(k) · Cleared
ClearedNihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Aug 29, 2008 as substantially equivalent to K992742 (Nihon Kohden America, Inc., 1999) after a 183-day review. Its family tree reaches back 2 generations to 1995. 11 later devices descend from it.
- Decided
- Aug 29, 2008
- Review
- 183 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944678 (1995). 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- 1 generation backK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- This deviceK080546 Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008
- 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 · cites it directly · 2 of its ownK113117 Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction…Nihon Kohden America, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK173868 Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK251366 EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit…Nihon Kohden Corporation · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · cites it directly6descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 2 generations on4descendants
- K113117Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction BoxNihon Kohden America, Inc. · 2012 · cites it directly2descendants
- K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018 · 3 generations on1descendant
- K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| −1 | K992742 | Neurofax, Model Eeg-1100A | Nihon Kohden America, Inc. | 1999 | — |
| 0 (this device) | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A | Nihon Kohden America, Inc. | 2008 | — |
| +1 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +2 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
| +1 | K113117 | Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box | Nihon Kohden America, Inc. | 2012 | — |
| +3 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018 | — |
| +1 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A)… | Nihon Kohden Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 2 | 0 |
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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K992742 | Neurofax, Model Eeg-1100ASummary page 1…el under 21 CFR Part 882.1400 Electroencephalograph per GWQ, QL‘j;_G 14 \V A Legally Marketed Predicate Device: Nihon Kohden EEG-1100A Series and Accessories per 510(k) K992742 commercial distribution certification dated October 14, 1999. Intended Use: The EEG-1200A Series Neurofax is intended to record… | 1999 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120888 | PSG-1100 Sleep Diagnostic System | 2012 | 6 |
| K113117 | Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box | 2012 | 2 |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A… | 2025 | 0 |
| K130238 | Nihon Kohden AE-918P Neuro Unit | 2015 | 0 |
| K131415 | Live View Panel (LVP) | 2013 | 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?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120888 (Nihon Kohden Corp., 2012) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K992742.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and
extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician
in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
The device is intended for use by medical personnel in any location within a medical
facility, laboratory, clinic or nursing home or outside of a medical facility under direct
supervision of a medical 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/K080546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080546
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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