510(k) · Cleared
ClearedDynamic Neuroscreening Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosenex · LQW Test, Temperature Discrimination
Cleared on Jul 23, 2014 as substantially equivalent to K864345 (Sensortek, Inc., 1987) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jul 23, 2014
- Review
- 75 days
- Class
- Class I
- Product code
- LQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843486 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK843486 VibrameterSomedic AB · 1984
- This deviceK141208 Dynamic Neuroscreening DeviceProsenex · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843486 | Vibrameter | Somedic AB | 1984 | — |
| 0 (this device) | K141208 | Dynamic Neuroscreening Device | Prosenex | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 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 LQW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K864345 | Nte-2 Thermal Sensitivity TesterSummary page 5…ich The Device Is Substantially Equivalent The Dynamic Neuroscreening Device is substantially equivalent to: ® The Sensortek NTE-2 Thermal Sensory Tester cleared under K864345. e The Somedic Vibrameter cleared under K843486. 5.7 Description Of The Device The Dynamic Neuroscreening Device (DND) is inten… | 1987 |
| * | K843486 | VibrameterSummary page 5…Dynamic Neuroscreening Device is substantially equivalent to: ® The Sensortek NTE-2 Thermal Sensory Tester cleared under K864345. e The Somedic Vibrameter cleared under K843486. 5.7 Description Of The Device The Dynamic Neuroscreening Device (DND) is intended to screen patients and . allow the practitio… | 1984 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LQW devicesLQW Test, Temperature Discrimination: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LQW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LQW
Too few LQW 510(k)s in any year since 2007 to give a median.
Recalls per year · LQW
No recall names LQW since 2007.
Adverse event reports per year · LQW
1in 2022
MAUDE reports naming product code LQW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dynamic Neuroscreening Device (DND) is intended to provide objective medical screening for peripheral neuropathy by determining the patient’s ability to discriminate temperature differences as well as determining vibration sensitivity.
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/K141208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141208: Dynamic Neuroscreening Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141208
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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