510(k) · Cleared
ClearedTwin Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grass-Telefactor Divison · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Feb 12, 2002 as substantially equivalent to K870450 (Grass-Telefactor Product Group, 1987) after a 160-day review. Its family tree reaches back 1 generation to 1987. 8 later devices descend from it.
- Decided
- Feb 12, 2002
- Review
- 160 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870450 (1987). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK870450 Szac-16 Seizure Analysis ComputerGrass-Telefactor Product Group · 1987
- This deviceK012976 Twin PlusGrass-Telefactor Divison · 2002
- Descendant · cites it directly · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · cites it directly · 2 of its ownK142064 Galileo NTEb Neuro S.P.A. · 2015
- Descendant · 2 generations on · 1 of its ownK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- Descendant · 3 generations on · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
- Descendant · 2 generations on · 0 of its ownK242832 NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173366NicoletOneNatus Neurology Incorporated · 2018 · cites it directly3descendants
- K142064Galileo NTEb Neuro S.P.A. · 2015 · cites it directly2descendants
- K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020 · 2 generations on1descendant
- K251881HippoMind (v1.0)Hippoclinic · 2025 · 3 generations on0descendants
- K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870450 | Szac-16 Seizure Analysis Computer | Grass-Telefactor Product Group | 1987 | — |
| 0 (this device) | K012976 | Twin Plus | Grass-Telefactor Divison | 2002 | — |
| +1 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +1 | K142064 | Galileo NT | Eb Neuro S.P.A. | 2015 | — |
| +2 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| +3 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
| +2 | K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (3)
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 |
|---|---|---|---|
| * | K870450 | Szac-16 Seizure Analysis ComputerSummary page 2…rm EEG Data Sequences (SZAC): The SZAC program module uses the identical software algorithm developed and proven in the SZAC Computer previously marketed by Telefactor (K870450) This system is in wide use in the medical community, particularly in epilepsy centers around the world. Grass-Telefactor makes n… | 1987 |
| * | — | GRASS GAMMA software Named without a submission number | |
| * | — | Telefactor BEEHIVE Named without a submission number |
What descends from it? (8)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K173366 (Natus Neurology Incorporated, 2018) has gone furthest, with 3 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 | — |
What is it indicated for?
This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, analysis, and archiving of EEG potentials and other rapidly changing physiological parameters.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012976: Twin Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012976
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026