510(k) · Cleared
Recalled · Class I · 2023Next Gen Emg Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · ETN Stimulator, Nerve
Cleared on Jun 27, 2012 as substantially equivalent to K094054 (Nuvasive, Inc., 2010) and 1 other predicate after a 286-day review. Its family tree reaches back 5 generations to 1985. 3 of the 16 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Jun 27, 2012
- Review
- 286 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 3 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K851426 (1985). 14 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 16 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 deviceK112686 Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK251672 NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG…Medtronic Xomed, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube…Medtronic Xomed, Inc. · 2026 · 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) | K112686 | Next Gen Emg Endotracheal Tube | Medtronic Xomed, Inc. | 2012 | — |
| +1 | K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal… | Medtronic Xomed, Inc. | 2026 | — |
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 |
|---|---|---|
| 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 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? (2)
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…Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class 11) Premarket Notification: K094054 Trade Name: Xomned EMG Endotracheal Tube Common/Usual Name: EMG El Tube… | 2010 |
| * | K925640 | Xomed-Treace Emg Endotracheal TubeenSummary page 1…Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class 11) Premarket Notification: K925640 G. Purpose of Submission: Design change in the material of the tube from silicone in the predicate device Xomed EMG Tube to PVC… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube… | 2026 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2023 | Class II | Z-0696-2024 | Under Investigation by firm | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, |
| Dec 22, 2021 | Class II | Z-0743-2022 | Process control | There is potential for multiple issues due to a manufacturing nonconformity. |
| Mar 4, 2013 | Class I | Z-1420-2013 | Use error | In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the… |
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 27 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, K251672 (Medtronic Xomed, Inc., 2026) has gone furthest, with 0 descendants 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. 2012, 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 Next Generation EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112686 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112686: Next Gen Emg Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112686
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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