510(k) · Cleared
ClearedNeurofax, Model Eeg-1100A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Oct 14, 1999 as substantially equivalent to K944678 (Nihon Kohden America, Inc., 1995) after a 59-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it.
- Decided
- Oct 14, 1999
- Review
- 59 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944678 (1995). 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- This deviceK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- Descendant · cites it directly · 11 of its ownK080546 Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK073491 Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK082629 S12X with Esax OptionChatten Associates, Inc. · 2009
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K080546Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc. · 2008 · cites it directly11descendants
- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · 2 generations on6descendants
- K073491Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008 · cites it directly5descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 3 generations on4descendants
- K082629S12X with Esax OptionChatten Associates, Inc. · 2009 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| 0 (this device) | K992742 | Neurofax, Model Eeg-1100A | Nihon Kohden America, Inc. | 1999 | — |
| +1 | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A | Nihon Kohden America, Inc. | 2008 | — |
| +2 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +1 | K073491 | Eeg-1100A Switch Box | Nihon Kohden America, Inc. | 2008 | — |
| +3 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
| +2 | K082629 | S12X with Esax Option | Chatten Associates, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2025 | 3 | 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 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
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 |
|---|---|---|---|
| * | K944678 | Nihon Kohden ElectroencephalographSummary page 1…mon names for the EEG-1100A device include Electroencephalograph (EEG) and Polysomnograph (PSG). The predicate marketed device is the Nihon Kohden EEG-2100 per 510(K) # K944678, commercial distribution certification dated 5/22/98. Nihon Kohden’s, model number EEG-1100A intended to record, measure and dis… | 1995 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K080546 (Nihon Kohden America, Inc., 2008) has gone furthest, with 11 descendants of its own.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EEG-1100A 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 Disorders, 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/K992742 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992742: Neurofax, Model Eeg-1100A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992742
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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