510(k) · Cleared
ClearedNIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)
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 Feb 10, 2026 as substantially equivalent to K112686 (Medtronic Xomed, Inc., 2012) after a 256-day review. Its family tree reaches back 6 generations to 1985. 3 of the 16 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 10, 2026
- Review
- 256 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K851426 (1985). 15 ancestors in all. No later device cites it as a predicate yet. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 5 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 4 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- 3 generations backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- 2 generations backK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- 1 generation backK112686 Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · Recalled (Class I)
- This deviceK251672 NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG…Medtronic Xomed, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −5 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −4 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| −3 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| −2 | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| −1 | K112686 | Next Gen Emg Endotracheal Tube | Medtronic Xomed, Inc. | 2012 | Class I |
| 0 (this device) | 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 |
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 K253536 Evala Nerve Stimulator (EPNR002)score 11.8 · 4 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 |
|---|---|---|---|
| * | K112686 | Next Gen Emg Endotracheal TubeSummary page 5…intended use and technological characteristics to the following predicate device: 510(k) Number 510(k) Device Name 510(k) Clearance Date K112686 NIM Trivantage™ EMG Endotracheal June 27, 2012 Tube NOTE: Product under K112686 was submitted and c… | 2012 |
| † | K073383 | Well Lead Reinforced Endotracheal Tube | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · Direct predicate · ◆ on the line of descent in 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
- K050162Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 6 companies; a new generation was cleared every 6.7 years on median.
- 5 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 EMG Tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251672: NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251672
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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