510(k) · Cleared
ClearedHarmonie Sensa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellate Systems · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Apr 4, 1996 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 4, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- OMB
- 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 OMB? 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 OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 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 OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems’ RHYTHM and MONITOR software. The software remains consistent with its original design objectives: to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology. to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards. to assist in the…
Read the full statement (148 words)
HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems’ RHYTHM and MONITOR software. The software remains consistent with its original design objectives:
to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology.
to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards.
to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities.
to complement the conventional continuous EEG recording, not replace it.
The software does not make any judgment of normality or abnormality of the displayed EEG or the results of an analysis. It is not intended for extended EEG monitoring used in critical care or intra-operative settings. In no way is the software or its function represented as being in and of itself 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/K960273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960273: Harmonie Sensa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960273
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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