510(k) · Cleared
ClearedNmi Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on May 15, 1995 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 466 devices in its family, counting itself, has a Class I recall. 465 later devices descend from it.
- Decided
- May 15, 1995
- Review
- 112 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 0
465 later devices descend from it, 1 citing it directly. 1 of the 466 devices in this family, counting this one, has a Class I recall.
- This deviceK950270 Nmi SoftwareNicolet Biomedical, Inc. · 1995
- Descendant · cites it directly · 464 of its ownK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- Descendant · 2 generations on · 463 of its ownK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- Descendant · 3 generations on · 462 of its ownK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- Descendant · 4 generations on · 460 of its ownK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- Descendant · 5 generations on · 450 of its ownK061113 OrthomonAxon Systems, Inc. · 2006
Showing 5 of 465 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub11 generations on · 2021
Most influential descendants
Showing 5 of 465 · See all- K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997 · cites it directly464descendants
- K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc. · 2002 · 2 generations on463descendants
- K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003 · 3 generations on462descendants
- K050798Eclipse Neurological WorkstationAxon Systems, Inc. · 2005 · 4 generations on460descendants
- K061113OrthomonAxon Systems, Inc. · 2006 · 5 generations on450descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950270 | Nmi Software | Nicolet Biomedical, Inc. | 1995 | — |
| +1 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| +2 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| +3 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| +4 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| +5 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 17 | 0 |
| 2018 | 20 | 0 |
| 2019 | 31 | 0 |
| 2020 | 22 | 0 |
| 2021 | 42 | 1 |
| 2022 | 48 | 0 |
| 2023 | 64 | 0 |
| 2024 | 62 | 0 |
| 2025 | 64 | 0 |
| 2026 | 57 | 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.
1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (465)
See all 4651 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971819 | Epoch 2000 Neurological Workstation | 1997 | 464 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 11 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K971819 (Axon Systems, Inc., 1997) has gone furthest, with 464 descendants of its own.
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 | — |
https://510kreport.com/device/K950270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950270: Nmi Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950270
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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