510(k) · Cleared
Recalled · Class I · 2022Contact Emg Rotatable 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 Mar 3, 2005 as substantially equivalent to K925640 (Xomed-Treace, Inc., 1993) and 1 other predicate after a 37-day review. Its family tree reaches back 1 generation to 1993. 3 of the 13 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 3, 2005
- Review
- 37 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925640 (1993). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK925640 Xomed-Treace Emg Endotracheal TubeenXomed-Treace, Inc. · 1993 · Recalled (Class I)
- This deviceK050162 Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK112686 Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK251672 NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG…Medtronic Xomed, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · cites it directly8descendants
- K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · 2 generations on4descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 3 generations on1descendant
- K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 2 generations on1descendant
- K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube…Medtronic Xomed, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925640 | Xomed-Treace Emg Endotracheal Tubeen | Xomed-Treace, Inc. | 1993 | Class I |
| 0 (this device) | K050162 | Contact Emg Rotatable Endotracheal Tube | Medtronic Xomed, Inc. | 2005 | — |
| +1 | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| +2 | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2011 | 10 |
| +3 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +2 | K112686 | Next Gen Emg Endotracheal Tube | Medtronic Xomed, Inc. | 2012 | Class I |
| +3 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 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 |
|---|---|---|---|
| * | K925640 | Xomed-Treace Emg Endotracheal TubeenSummary page 1…Cuff (per 21 CFR §868.5730 and 868.5750) * FDA Classification: Class II Predicate * Xomed EMG Endotracheal Tubes (K925640)., and Device(s) * RLN Systems Inc., Laryngeal Surface Electrode-Endotracheal Tube (LSE-ET) (K00374… | 1993 |
| * | K003745 | Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ETSummary page 1…* Xomed EMG Endotracheal Tubes (K925640)., and Device(s) * RLN Systems Inc., Laryngeal Surface Electrode-Endotracheal Tube (LSE-ET) (K003745) Description of The CONTACT TM EMG Rotatable Endotracheal Tube is a flexible, Device cuffed, Endotracheal tube manu… | 2001 |
What descends from it? (10)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2022 | Class I | Z-1519-2022 | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. |
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?
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CONTACTTM EMG Rotatable 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 intrinsic laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use where 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/K050162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050162: Contact Emg Rotatable Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050162
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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