510(k) · Cleared
ClearedModifcation to: Nuvasive Neurovision Emg Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on May 14, 2010 as substantially equivalent to K090298 (Nuvasive, Inc., 2009) and 2 other predicates after a 134-day review. Its family tree reaches back 4 generations to 1985. 3 of the 22 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- May 14, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K851426 (1985). 13 ancestors in all. 8 later devices descend from it, 3 citing it directly. 3 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 3 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 2 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- 1 generation backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- This deviceK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK112686 Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK251672 NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG…Medtronic Xomed, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK242852 ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7…Inomed Medizintechnik GmbH · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · cites it directly4descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 2 generations on1descendant
- K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · cites it directly1descendant
- K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube…Medtronic Xomed, Inc. · 2026 · 2 generations on0descendants
- K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…Inomed Medizintechnik GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −3 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −2 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| −1 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| +1 | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2011 | 10 |
| +2 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +1 | K112686 | Next Gen Emg Endotracheal Tube | Medtronic Xomed, Inc. | 2012 | Class I |
| +2 | K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal… | Medtronic Xomed, Inc. | 2026 | — |
| +2 | K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845)… | Inomed Medizintechnik GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 1 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
3 devices in this family have a Class I recall. 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 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 |
|---|---|---|---|
| * | K090298 | Nuvasive Neuro Vision SystemSummary page 1…ct Neuro Vision® EMG Endotracheal Tube is substantially equivalent to the following predicate devices currently distributed commercially in the U.S.: • K090298 -NuVasive NeuroVision EMG Endotracheal]Tube * K032491 - ECOMTM CV4 Endotracheal Cardiac Output Monitor * K0… | 2009 |
| * | K032491 | Ecom CV4 Endotracheal Cardiac Output MonitorSummary page 1…t to the following predicate devices currently distributed commercially in the U.S.: • K090298 -NuVasive NeuroVision EMG Endotracheal]Tube * K032491 - ECOMTM CV4 Endotracheal Cardiac Output Monitor * K050 162 - ContactTm EMG Rotatable Endotracheal Tube D. Device… | 2003 |
| * | K050162 | Contact Emg Rotatable Endotracheal TubeSummary page 1…ercially in the U.S.: • K090298 -NuVasive NeuroVision EMG Endotracheal]Tube * K032491 - ECOMTM CV4 Endotracheal Cardiac Output Monitor * K050 162 - ContactTm EMG Rotatable Endotracheal Tube D. Device Description The Nu Vasive® Neuro Vision®R EMG Endotracheal (ET)… | 2005 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050162Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K925640Xomed-Treace Emg Endotracheal TubeenXomed-Treace, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 11 Class I recall
- K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- 4 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K110989 (Neurovision Medical Products, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The NeuroVision EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K094054
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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