# K141208: Dynamic Neuroscreening Device

- Pathway: 510(k) (Traditional)
- Applicant: Prosenex
- Decided: Jul 23, 2014 after 75 days
- Product code: LQW (Test, Temperature Discrimination)
- Device class: 1
- Regulation: 21 CFR 882.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K843486 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864345: Nte-2 Thermal Sensitivity Tester, Sensortek, Inc. (1987) Summary page 5.
- K843486: Vibrameter, Somedic AB (1984) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K141208
Methodology: https://510kreport.com/methodology