510(k) · Cleared
Recalled · Class II · 2024Neurovision Ink Printed Endotracheal Tube Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Medical Products, Inc. · ETN Stimulator, Nerve
Cleared on Nov 3, 2011 as substantially equivalent to K094054 (Nuvasive, Inc., 2010) after a 209-day review. Its family tree reaches back 5 generations to 1985. 2 of the 19 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 10 times.
- Decided
- Nov 3, 2011
- Review
- 209 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 5 generations to K851426 (1985). 14 ancestors in all. 4 later devices descend from it, 3 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 4 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 3 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- 2 generations backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- 1 generation backK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- This deviceK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK130806 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · cites it directly1descendant
- 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 · cites it directly0descendants
- K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 2 generations on0descendants
- K130806Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −4 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −3 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| −2 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| −1 | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| 0 (this device) | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2011 | — |
| +1 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +1 | 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 | — |
| +2 | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | 2 |
| +1 | K130806 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
2 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 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? (1)
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 |
|---|---|---|---|
| * | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeSummary page 1…t Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the following predicate devices concurrently distributed commercially inthe U.S.: *K094054 NuVasive EMS Endlotracheal Tube Device Description The Neurovision Ink Printed Endotracheal Tube Electrode is an endlotracheal tu… | 2010 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2024 | Class II | Z-2719-2024 | Process control | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. |
| Jul 21, 2020 | Class II | Z-2900-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2905-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2904-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2903-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2906-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2901-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2908-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2907-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
| Jul 21, 2020 | Class II | Z-2902-2020 | Under Investigation by firm | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal… |
The 5 latest of 10 recalls; the web page lists all.
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.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 4 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K221821 (Alphatec Spine, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K094054.
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 Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110989: Neurovision Ink Printed Endotracheal Tube Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110989
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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