510(k) · Cleared
ClearedBaxano Neural Localization Probe 1.75 and 1.25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxano, Inc. · ETN Stimulator, Nerve
Cleared on Sep 17, 2008 as substantially equivalent to K080494 (Baxano, Inc., 2008) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it.
- Decided
- Sep 17, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K980148 (1998). 17 ancestors in all, the oldest K842956 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 3 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 2 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 1 generation backK031510 Nim-SpineMedtronic Xomed · 2003
- This deviceK081742 Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK092729 Baxano Neuro Check DeviceBaxano, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −3 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −2 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −1 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| 0 (this device) | K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | Baxano, Inc. | 2008 | — |
| +1 | K092729 | Baxano Neuro Check Device | Baxano, Inc. | 2009 | — |
| +2 | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K080494 | Baxano Ultra Low Profile RongeurSummary page 1…on device (per 21 CFR section 874.1820) Probe for skull or spinal column (per 21 CFR section 882.4840) Predicate Devices: Baxano Standard Probe (K080494), Medtronic Xomed NIM Spine (K03 1510O), WR Medical Dual Stim Nerve Stimulator (K063560) and… | 2008 |
| * | K031510 | Nim-SpineSummary page 1…Probe for skull or spinal column (per 21 CFR section 882.4840) Predicate Devices: Baxano Standard Probe (K080494), Medtronic Xomed NIM Spine (K03 1510O), WR Medical Dual Stim Nerve Stimulator (K063560) and NuVasive NeuroVision JiB System (KO5 1384) Device D… | 2003 |
| * | K063560 | Hilger Dual-Stim Nerve StimulatorSummary page 1…tion 882.4840) Predicate Devices: Baxano Standard Probe (K080494), Medtronic Xomed NIM Spine (K03 1510O), WR Medical Dual Stim Nerve Stimulator (K063560) and NuVasive NeuroVision JiB System (KO5 1384) Device Description: The Neural Localization Probe is bas… | 2007 |
| * | K051384 | Modification to: Nuvasive Neurovision JJB System | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092729 | Baxano Neuro Check Device | 2009 | 1 |
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 10 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K092729 (Baxano, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K080494.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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, Inc. Neural Localization Probe is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081742: Baxano Neural Localization Probe 1.75 and 1.25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081742
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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