510(k) · Cleared
ClearedPaired Hydrogel Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Medical Products, Inc. · ETN Stimulator, Nerve
Cleared on Apr 8, 2011 as substantially equivalent to K092744 (R & D Medical Products, Inc., 2009) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Apr 8, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011564 (2002). 5 ancestors in all, the oldest K902080 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK011564 NeoleadNeotech Products, Inc. · 2002
- 2 generations backK050443 Accu-LeadKentec Medical, Inc. · 2005
- 1 generation backK092744 Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009
- This deviceK110138 Paired Hydrogel ElectrodeNeurovision Medical Products, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011564 | Neolead | Neotech Products, Inc. | 2002 | — |
| −2 | K050443 | Accu-Lead | Kentec Medical, Inc. | 2005 | — |
| −1 | K092744 | Neonatal Ecg Electrode, M203KEN | R & D Medical Products, Inc. | 2009 | — |
| 0 (this device) | K110138 | Paired Hydrogel Electrode | Neurovision Medical Products, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K092744 | Neonatal Ecg Electrode, M203KENSummary page 1…rodes are substantially equivalent to the following predicate devices currently distributed commercially in the U.S.: " M2O3KEN; Neonatal ECG Electrode (K092744), referred to in this document as the Singlet Hydrogel (K092744) " 3M Pediatric "Red Dot" hydrogel elec… | 2009 |
| * | K902080 | Red Dot 2269 Infant Monitoring ElectrodeSummary page 1…the Singlet Hydrogel (K092744) " 3M Pediatric "Red Dot" hydrogel electrode accessory RLN Systems Nerve Locator/Monitor; Model A (K902080), superseded by, " Neurovision (SE: Surface Electrode) Nerve Locator/Monitor (K954601) Device Description The P… | 1990 |
| * | K954601 | Nerve Locator/Monitor System ModificationSummary page 1…ode accessory RLN Systems Nerve Locator/Monitor; Model A (K902080), superseded by, " Neurovision (SE: Surface Electrode) Nerve Locator/Monitor (K954601) Device Description The Paihred Hydra gel Electrodes are a modification of the M2O3KEN electrode currently distributed as… | 1995 |
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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K092744.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110138: Paired Hydrogel Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110138
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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