510(k) · Cleared
ClearedSzac-16 Seizure Analysis Computer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grass-Telefactor Product Group · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Apr 8, 1987 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Apr 8, 1987
- Review
- 64 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK870450 Szac-16 Seizure Analysis ComputerGrass-Telefactor Product Group · 1987
- Descendant · cites it directly · 8 of its ownK012976 Twin PlusGrass-Telefactor Divison · 2002
- Descendant · 2 generations on · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · 2 generations on · 2 of its ownK142064 Galileo NTEb Neuro S.P.A. · 2015
- Descendant · 3 generations on · 1 of its ownK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- Descendant · 4 generations on · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K012976Twin PlusGrass-Telefactor Divison · 2002 · cites it directly8descendants
- K173366NicoletOneNatus Neurology Incorporated · 2018 · 2 generations on3descendants
- K142064Galileo NTEb Neuro S.P.A. · 2015 · 2 generations on2descendants
- K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020 · 3 generations on1descendant
- K251881HippoMind (v1.0)Hippoclinic · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870450 | Szac-16 Seizure Analysis Computer | Grass-Telefactor Product Group | 1987 | — |
| +1 | K012976 | Twin Plus | Grass-Telefactor Divison | 2002 | — |
| +2 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +2 | K142064 | Galileo NT | Eb Neuro S.P.A. | 2015 | — |
| +3 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| +4 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012976 | Twin Plus | 2002 | 8 |
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.
What does this lineage say?
- Of its descendants, K012976 (Grass-Telefactor Divison, 2002) has gone furthest, with 8 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/K870450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K870450: Szac-16 Seizure Analysis Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870450
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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