510(k) · Cleared
Recalled · Class II · 2009Harmone-Schwarzer Eeg System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellate Systems · OLV Standard Polysomnograph With Electroencephalograph
Cleared on May 21, 2001 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it. It has been recalled once.
- Decided
- May 21, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- OLV
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK010728 Harmone-Schwarzer Eeg SystemStellate Systems · 2001
- Descendant · cites it directly · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · 4 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · cites it directly14descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 2 generations on7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 3 generations on5descendants
- K173366NicoletOneNatus Neurology Incorporated · 2018 · 2 generations on3descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010728 | Harmone-Schwarzer Eeg System | Stellate Systems | 2001 | — |
| +1 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +2 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +3 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +2 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +4 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 162 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)
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?
- Of its descendants, K080217 (Moberg Research, Inc., 2008) has gone furthest, with 14 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/K010728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010728: Harmone-Schwarzer Eeg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010728
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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