510(k) · Cleared
Recalled · Class II · 2013Nicolet Wireless Eeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 209, Inc. · GWL Amplifier, Physiological Signal
Cleared on Apr 8, 2011 as substantially equivalent to K061908 (Viasys Neuro Care, 2006) and 6 other predicates after a 165-day review. Its family tree reaches back 4 generations to 2000. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 8, 2011
- Review
- 165 days
- Class
- Class II
- Product code
- GWL
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 4 generations to K001564 (2000). 13 ancestors in all, the oldest K964280 (1997). 7 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 3 generations backK023536 NuampsNeuroscan · 2003
- 2 generations backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- 1 generation backK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- This deviceK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK170441 ElectroTekMobilemedtek · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK162681 Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017
- Descendant · cites it directly · 1 of its ownK151600 R-40 EEG AmplifierLifelines, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK261604 Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio…Neuroelectrics Barcelona S.L.U. · 2026
- Descendant · 2 generations on · 0 of its ownK212788 Seer HomeSeer Medical Pty, Ltd. · 2022 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170441ElectroTekMobilemedtek · 2017 · cites it directly1descendant
- K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017 · cites it directly1descendant
- K151600R-40 EEG AmplifierLifelines, Ltd. · 2015 · cites it directly1descendant
- K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U. · 2026 · 2 generations on0descendants
- K212788Seer HomeSeer Medical Pty, Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −3 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −2 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| −1 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| 0 (this device) | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | — |
| +1 | K170441 | ElectroTek | Mobilemedtek | 2017 | 2 |
| +1 | K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017 | — |
| +1 | K151600 | R-40 EEG Amplifier | Lifelines, Ltd. | 2015 | — |
| +2 | K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | 2026 | — |
| +2 | K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 GWL? 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 GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K061908 | Nicoletone System V32 AmplifierSummary page 1…Legally marketed device(s) 51OWkI#: Cleared on: Name Code: to which equivalence is K061908 1110612006 NicoletOne V32 Amplifier with Oximetry GWO claimed K09095… | 2006 |
| * | K090957 | Blackrock Neuroport Biopotential Signal Processing SystemSummary page 1…to which equivalence is K061908 1110612006 NicoletOne V32 Amplifier with Oximetry GWO claimed K090957 05128/2009 Blackrock Neuroport Biopotential Signal Processing System OWL K06052… | 2009 |
| * | K060523 | Neuroport Neural Signal Processing SystemSummary page 1…claimed K090957 05128/2009 Blackrock Neuroport Biopotential Signal Processing System OWL K060523 03/28/2006 NeuroPort Instrument GWO K06080… | 2006 |
| * | K060803 | G.UsbampSummary page 1…K060523 03/28/2006 NeuroPort Instrument GWO K060803 0510212006 gUSBamp GWL K<0401… | 2006 |
| * | K040113 | Sandman SD20 AmplifierSummary page 1…K060803 0510212006 gUSBamp GWL K<040113 02/1812004 Sandman 5020 Amplifier GWL K<03347… | 2004 |
| * | K033475 | Wireless Input Unit, Model Wee-1000A SeriesSummary page 2…Substantially equivalent to the Nihon Kohden WEE-100O Wireless Amplifier (K033475) System components comprised of tel… | 2004 |
| * | K003175 | Compumedics Siesta SystemSummary page 1…K<033475 0110712004 Nihon Kohden WEE-i 000 Wireless Amplifier GWO K003175 12/27/2000 Siesta compumnedics OWO Reason far 51 0(k) The c… | 2000 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2013 | Class II | Z-0946-2013 | Nonconforming Material/Component | Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K170441 (Mobilemedtek, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K061908.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit efectrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103140: Nicolet Wireless Eeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103140
Report an extraction error
Are you the manufacturer?
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