510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141208Substantially Equivalent

Dynamic Neuroscreening Device

Prosenex, Leola PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141208 is the FDA 510(k) clearance record for DYNAMIC NEUROSCREENING DEVICE, a class I device, cleared for Prosenex on under FDA product code LQW (Test, Temperature Discrimination). FDA records list one 510(k) clearance for Prosenex. As of , FDA records show no recalls naming K141208.

Clearance record

Decision date
Received
(75 days to decision)
Product code
LQW Test, Temperature Discrimination
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Applicant
Prosenex 342 E. Main St., Leola PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQW

Trailing 12 months

FDA records hold no clearances under product code LQW in the trailing twelve months.

FDA records show no clearances under product code LQW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260