510(k) · Cleared
ClearedNIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced 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 Oct 26, 2023 as substantially equivalent to K925640 (Xomed-Treace, Inc., 1993) and 1 other predicate after a 262-day review. Its family tree reaches back 2 generations to 1993. 2 of the 4 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 26, 2023
- Review
- 262 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925640 (1993). 3 ancestors in all. No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK925640 Xomed-Treace Emg Endotracheal TubeenXomed-Treace, Inc. · 1993 · Recalled (Class I)
- 1 generation backK050162 Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · Recalled (Class I)
- This deviceK230320 NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced…Medtronic Xomed, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925640 | Xomed-Treace Emg Endotracheal Tubeen | Xomed-Treace, Inc. | 1993 | Class I |
| −1 | K050162 | Contact Emg Rotatable Endotracheal Tube | Medtronic Xomed, Inc. | 2005 | Class I |
| 0 (this device) | K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG… | Medtronic Xomed, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 4…Name Product Regulation 510(k) Code Number Clearance Date K925640 Xomed-Treace EMG ETN 21 CFR 874.1820 August 17, 1993 Endotrache… | 1993 |
| * | K050162 | Contact Emg Rotatable Endotracheal TubeSummary page 4…Clearance Date K925640 Xomed-Treace EMG ETN 21 CFR 874.1820 August 17, 1993 Endotracheal Tube K050162 CONTACT™ EMG ETN 21 CFR 874.1820 March 3, 2005 Rotatable En… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 18.6 years on median.
- 3 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
- 4 other devices also cite its predicate K925640.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K230320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230320: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG 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/K230320
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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