510(k) · Cleared
ClearedNeurofax, Models Eeg-1100A, Eeg-9100A
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 May 8, 2001 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- May 8, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK011204 Neurofax, Models Eeg-1100A, Eeg-9100ANihon Kohden America, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK022121 PSG Input Box, Model JE-912AKNihon Kohden America, Inc. · 2002
- Descendant · 2 generations on · 7 of its ownK062943 Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007
- Descendant · 2 generations on · 7 of its ownK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- Descendant · 2 generations on · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- Descendant · 3 generations on · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K022121PSG Input Box, Model JE-912AKNihon Kohden America, Inc. · 2002 · cites it directly9descendants
- K062943Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007 · 2 generations on7descendants
- K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005 · 2 generations on7descendants
- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · 2 generations on6descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011204 | Neurofax, Models Eeg-1100A, Eeg-9100A | Nihon Kohden America, Inc. | 2001 | — |
| +1 | K022121 | PSG Input Box, Model JE-912AK | Nihon Kohden America, Inc. | 2002 | — |
| +2 | K062943 | Polysmith Sleep System, Model NTI5498 | Neurotronics, Inc. | 2007 | — |
| +2 | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| +2 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +3 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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?
- Of its descendants, K022121 (Nihon Kohden America, Inc., 2002) has gone furthest, with 9 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 | — |
https://510kreport.com/device/K011204 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011204: Neurofax, Models Eeg-1100A, Eeg-9100A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011204
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026