510(k) · Cleared
ClearedNeuro Check Device with IO-Flex Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxano, Inc. · ETN Stimulator, Nerve
Cleared on Jul 7, 2011 as substantially equivalent to K092729 (Baxano, Inc., 2009) and 4 other predicates after a 115-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Jul 7, 2011
- Review
- 115 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K842956 (1984). 37 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 5 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 4 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 3 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 2 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 1 generation backK061113 OrthomonAxon Systems, Inc. · 2006
- This deviceK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −5 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −4 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −3 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −2 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −1 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| 0 (this device) | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K092729 | Baxano Neuro Check DeviceSummary page 1…Preicte evceCode Number Date Baxano Neuro CheckTM Device ETh K092729 10/02/2009 NuVasive NeuroVision JJB and GWF K062765 0 1/24/2007 M5 Sys… | 2009 |
| * | K062765 | Modification to Nuvasive Neurovision JJB SystemSummary page 1…ber Date Baxano Neuro CheckTM Device ETh K092729 10/02/2009 NuVasive NeuroVision JJB and GWF K062765 0 1/24/2007 M5 System and Probes Medtronic NIM Eclipse and Probes (for… | 2007 |
| * | K061113 | OrthomonSummary page 1…62765 0 1/24/2007 M5 System and Probes Medtronic NIM Eclipse and Probes (formerly Axon Systems GWF, IKN K061 113 05/23/2006 OrthoMon System) Cadwell Sierra Wave GWF K924723 03… | 2006 |
| * | K924723 | Cadwell SierraSummary page 1…Probes (formerly Axon Systems GWF, IKN K061 113 05/23/2006 OrthoMon System) Cadwell Sierra Wave GWF K924723 03/23/1 993 EMG/NCV/EP ____ ____… | 1993 |
| * | K100958 | Modification to: Microblade Shaver and AccessoriesSummary page 2…distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K1 00958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience.… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 37 ancestors have a recall of any class.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Baxano Neuro CheckTM Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.
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/K110696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110696: Neuro Check Device with IO-Flex Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110696
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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