510(k) · Cleared
ClearedGrass TS3201/6401 Eeg Amplifier System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grass Instrument Co. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Mar 6, 2000 as substantially equivalent to K973883 (Bio-Logic Systems Corp., 1998) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1989. 6 later devices descend from it.
- Decided
- Mar 6, 2000
- Review
- 89 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K884937 (1989). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 3 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 2 generations backK974587 H2OGrass-Telefactor Product Group · 1998
- 1 generation backK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- This deviceK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- Descendant · cites it directly · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · 3 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · 4 generations on · 1 of its ownK133995 Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015
- Descendant · 5 generations on · 0 of its ownK220254 Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K050425Aura-PSGAstro-Med, Inc. · 2005 · cites it directly5descendants
- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · 2 generations on4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 3 generations on3descendants
- K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015 · 4 generations on1descendant
- K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −3 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −2 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| −1 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| 0 (this device) | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| +1 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| +2 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +3 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +4 | K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | Neurosoft, Ltd. | 2015 | — |
| +5 | K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K973883 | Bio-Logic Ceegraph 128-Channel Recording SystemSummary page 1…GWQ, Class [, per 882.1400 3. Equivalent Devices This product is similar in design, function, and intended use to the Bio-Logic CEEGRAPH 128-channel Recording System (K973883) and the Telcfactor H20 “Tethered-option” EEG recorder system (K992291). Like these equivalent products, the Gras… | 1998 |
| * | K992291 | H20- Tethered OptionSummary page 1…ilar in design, function, and intended use to the Bio-Logic CEEGRAPH 128-channel Recording System (K973883) and the Telcfactor H20 “Tethered-option” EEG recorder system (K992291). Like these equivalent products, the Grass® TS3201/6401 is designed to provide the signal conditioning interface… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050425 | Aura-PSG | 2005 | 5 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K050425 (Astro-Med, Inc., 2005) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K973883.
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?
The TS3201/6401 amplifier system is designed for use in the recording of routine EEG,
long-term EEG with patient video and overnight sleep/EEG recording applications
(Polysomnography). This device is intended to be used only by physicians, technicians,
or other medical professionals that are trained in electroencephalography.
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/K994142 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994142: Grass TS3201/6401 Eeg Amplifier System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994142
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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