510(k) · Cleared
ClearedAura-PSG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astro-Med, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Oct 20, 2005 as substantially equivalent to K994142 (Grass Instrument Co., 2000) and 2 other predicates after a 244-day review. Its family tree reaches back 5 generations to 1989. 5 later devices descend from it.
- Decided
- Oct 20, 2005
- Review
- 244 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K884937 (1989). 11 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 4 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 3 generations backK974587 H2OGrass-Telefactor Product Group · 1998
- 2 generations backK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- 1 generation backK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- This deviceK050425 Aura-PSGAstro-Med, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · 2 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · 3 generations on · 1 of its ownK133995 Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015
- Descendant · 4 generations on · 0 of its ownK220254 Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK171384 Micromed BRAIN QUICK systemMicromed S.P.A. · 2018 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · cites it directly4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 2 generations on3descendants
- K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015 · 3 generations on1descendant
- K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022 · 4 generations on0descendants
- K171384Micromed BRAIN QUICK systemMicromed S.P.A. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −4 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −3 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| −2 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| −1 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| 0 (this device) | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| +1 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +2 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +3 | K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | Neurosoft, Ltd. | 2015 | — |
| +4 | K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft, Ltd. | 2022 | — |
| +2 | K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K994142 | Grass TS3201/6401 Eeg Amplifier SystemSummary page 1…GWO Product Class: Class 1IDevice This device claims substantial equivalence to the following: Grass-Telefactor TS3201/6401: 510(k) number K•994142 Grass-Telefactor AS-40 Amplifier: 510(k) number K•021807 Grass-Telefactor AURA Amplifier: 510(k) number K0… | 2000 |
| * | K021807 | Grass-Telefactor AS40 Amplifier SystemSummary page 1…ubstantial equivalence to the following: Grass-Telefactor TS3201/6401: 510(k) number K•994142 Grass-Telefactor AS-40 Amplifier: 510(k) number K•021807 Grass-Telefactor AURA Amplifier: 510(k) number K033978 Intended Use: The AURA-PSG amplifier system is intended for… | 2002 |
| * | K033978 | ADAMSummary page 1…S3201/6401: 510(k) number K•994142 Grass-Telefactor AS-40 Amplifier: 510(k) number K•021807 Grass-Telefactor AURA Amplifier: 510(k) number K033978 Intended Use: The AURA-PSG amplifier system is intended for recording routine Electroencephalography (EEG) and Polysomnography… | 2004 |
| † | K012976 | Twin Plus | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | 2008 | 4 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K071782 (Micromed S.P.A., 2008) has gone furthest, with 4 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?
The AURA-PSG amplifier system is intended for recording routine
Electroencephalography (EEG) and Polysomnography (PSG).
This device is intended to be used only by physicians, technicians, or other medical
professionals that are trained in EEG and/or PSG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050425: Aura-PSG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050425
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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