510(k) · Cleared
ClearedLUNA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellate Systems · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Jul 29, 1998 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 29, 1998
- Review
- 23 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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.
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 indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems’ ECLIPSE Version 3.0 software for MS-DOS®. Luna™ can be used only in conjunction with Stellate Systems’ HARMONIE™ software package. Luna™ may be used for sleep recordings (polysomnography) in research or clinical environments for: • Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional…
Read the full statement (235 words)
The indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems’ ECLIPSE Version 3.0 software for MS-DOS®.
Luna™ can be used only in conjunction with Stellate Systems’ HARMONIE™ software package.
Luna™ may be used for sleep recordings (polysomnography) in research or clinical environments for:
• Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers, by means of a personal computer (PC) and PC-based data acquisition board.
• Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages.
• Manual event-marking and annotation of polygraphic signal sections.
• Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals.
• Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency, and simple statistical measures of marked events).
The software is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings.
The software requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgment in using this information.
The software does not make any judgment of normality or abnormality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982351: LUNA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982351
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026