510(k) · Cleared
Recalled · Class II · 2009Harmonie System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellate Systems · GWQ Full-Montage Standard Electroencephalograph
Cleared on Aug 29, 2011 as substantially equivalent to K010728 (Stellate Systems, 2001) and 1 other predicate after a 999-day review. Its family tree reaches back 3 generations to 2001. It has been recalled once.
- Decided
- Aug 29, 2011
- Review
- 999 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003154 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −2 | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| −1 | K053606 | BE Plus / Aura-LTM64 Amplifier | Eb Neuro S.P.A. | 2006 | — |
| 0 (this device) | K083577 | Harmonie System | Stellate Systems | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 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? (2)
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 |
|---|---|---|---|
| * | K010728 | Harmone-Schwarzer Eeg System | 2001 |
| * | K053606 | BE Plus / Aura-LTM64 AmplifierSummary page 1…sification name - EEG/PSG Monitoring (21 CFR 882.1400 Product Code GWQ) The Harmonie System is substantially equivalent to K(01 0728 - Harmonie Schwarzer EEG System and K053606 - BE Plus / AURA-LTM64 Amplifier. Device Description: The Harmonie System is a data acquisition device that can record up to 128… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2009 | Class II | Z-1080-2013 | No Marketing Application | The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K010728.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Harmonie System is indicated for the acquisition, display, review, analysis and archiving of physiological signals including patient video obtained during routine EEG examinations, Long-Term Monitoring in Epilepsy (LTM) and Sleep Studies (polysomnography or PSG) in patients of all ages. The seizure detection component of the software is intended for post-hoc review for marking sections of the EEG that may correspond to electrographic seizures in…
Read the full statement (178 words)
The Harmonie System is indicated for the acquisition, display, review, analysis and archiving of physiological signals including patient video obtained during routine EEG examinations, Long-Term Monitoring in Epilepsy (LTM) and Sleep Studies (polysomnography or PSG) in patients of all ages.
The seizure detection component of the software is intended for post-hoc review for marking sections of the EEG that may correspond to electrographic seizures in adults only. The Burst-Suppression component is intended to be used for the quantification and recognition (mark) of sections of the EEG and PSG that may contain patterns of interest. The seizure detection component and Burst-Suppression Module are for use in adults only.
The Harmonie software is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings.
In no way are any of the system functions represented as being in and of themselves diagnostic. The system requires competent user input, and its Output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083577: Harmonie System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083577
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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