510(k) · Cleared
ClearedEeg-1100A Switch Box
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 Jan 11, 2008 as substantially equivalent to K992742 (Nihon Kohden America, Inc., 1999) after a 30-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 11, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944678 (1995). 5 later devices descend from it, 1 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 deviceK073491 Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK082629 S12X with Esax OptionChatten Associates, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK151354 Cervello STIMBlackrock Neuromed · 2016
- Descendant · 3 generations on · 1 of its ownK180761 SD LTM STIM Cortical StimulatorMicromed S.P.A. · 2018
- Descendant · 4 generations on · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK173684 g.Estim PROG.Tec Medical Engineering GmbH · 2018
Most influential descendants
Showing 5 of 5 · See all- K082629S12X with Esax OptionChatten Associates, Inc. · 2009 · cites it directly4descendants
- K151354Cervello STIMBlackrock Neuromed · 2016 · 2 generations on2descendants
- K180761SD LTM STIM Cortical StimulatorMicromed S.P.A. · 2018 · 3 generations on1descendant
- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc. · 2025 · 4 generations on0descendants
- K173684g.Estim PROG.Tec Medical Engineering GmbH · 2018 · 2 generations on0descendants
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) | K073491 | Eeg-1100A Switch Box | Nihon Kohden America, Inc. | 2008 | — |
| +1 | K082629 | S12X with Esax Option | Chatten Associates, Inc. | 2009 | — |
| +2 | K151354 | Cervello STIM | Blackrock Neuromed | 2016 | — |
| +3 | K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018 | — |
| +4 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
| +2 | K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K992742 | Neurofax, Model Eeg-1100ASummary page 1…lassification Panel under 21 CFR Part 882.1400 Electroencephalograph per GWQ , O LV Legally Marketed Predicate Device: Nihon Kohden EEG-1100A and Accessories per 510(k) 992742 commercial distribution certification dated October 14, 1999. Intended Use: The EEG-1100A Switch Boxes product is connected bet… | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082629 | S12X with Esax Option | 2009 | 4 |
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 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082629 (Chatten Associates, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K992742.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 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 or 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/K073491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073491: Eeg-1100A Switch Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073491
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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