510(k) · Cleared
ClearedLaryngeal Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · ETN Stimulator, Nerve
Cleared on Aug 28, 2012 as substantially equivalent to K093373 (Spes Medica Srl, 2010) and 1 other predicate after a 124-day review. Its family tree reaches back 3 generations to 1993. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 28, 2012
- Review
- 124 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925640 (1993). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK925640 Xomed-Treace Emg Endotracheal TubeenXomed-Treace, Inc. · 1993 · Recalled (Class I)
- 2 generations backK071349 Neurosign Laryngeal ElectrodesThe Magstim Company, Ltd. · 2007
- 1 generation backK093373 Laryngeal Surface ElectrodeSpes Medica Srl · 2010 · Recalled
- This deviceK121257 Laryngeal ElectrodeTechnomed Europe · 2012
Class I recalls in this family
- K925640 Xomed-Treace Emg Endotracheal Tubeen2 generations back · 1993
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925640 | Xomed-Treace Emg Endotracheal Tubeen | Xomed-Treace, Inc. | 1993 | Class I |
| −2 | K071349 | Neurosign Laryngeal Electrodes | The Magstim Company, Ltd. | 2007 | — |
| −1 | K093373 | Laryngeal Surface Electrode | Spes Medica Srl | 2010 | 2 |
| 0 (this device) | K121257 | Laryngeal Electrode | Technomed Europe | 2012 | — |
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.
1 device in this family has 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 |
|---|---|---|---|
| * | K093373 | Laryngeal Surface ElectrodeSummary page 1…sable Laryngeal Electrode is classified as class 11 per 21 CER section 874.1820. Product code ETN. Substantial Equivalence: K093373: Dragonfly Laryngeal Surface Electrode K07 1349: Neurosign Laryngeal Electrode Device… | 2010 |
| * | K071349 | Neurosign Laryngeal ElectrodesSummary page 1…21 CER section 874.1820. Product code ETN. Substantial Equivalence: K093373: Dragonfly Laryngeal Surface Electrode K07 1349: Neurosign Laryngeal Electrode Device description: Disposable Laryngeal Electrodes are non-invasive. The… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K925640Xomed-Treace Emg Endotracheal TubeenXomed-Treace, Inc. · 1993 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has 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. 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?
Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121257: Laryngeal Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121257
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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