510(k) · Cleared
ClearedNicolet Electrocautery Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · ETN Stimulator, Nerve
Cleared on Apr 17, 2002 as substantially equivalent to K934426 (Xomed-Treace, Inc., 1994) after a 23-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 17, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934426 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- This deviceK020955 Nicolet Electrocautery DetectorNicolet Biomedical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| 0 (this device) | K020955 | Nicolet Electrocautery Detector | Nicolet Biomedical, Inc. | 2002 | — |
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.
Planning a device in ETN? 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? (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 |
|---|---|---|---|
| * | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL)Summary page 1…rch 20, 2002 Trade Name: Electrocautery Detector Common Name: Nerve Stimulator Classification Name: 21 CFR 874.1820; Product Code: ETN Predicate Device: 510(k) Number: K934426 Manufacture: XOMED-TREACE, Inc. Trade Name: Nerve Integrity Monitor-2 (NIM-2 XL) 1.0 Description of Device The Nicolet Electroca… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K934426.
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 Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020955: Nicolet Electrocautery Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020955
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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