510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864345Substantially Equivalent

Nte-2 Thermal Sensitivity Tester

Sensortek, Inc., Clifton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864345 is the FDA 510(k) clearance record for NTE-2 THERMAL SENSITIVITY TESTER, a class I device, cleared for Sensortek, Inc. on under FDA product code LQW (Test, Temperature Discrimination). FDA records list 5 510(k) clearances for Sensortek, Inc., from to . As of , FDA records show no recalls naming K864345.

Clearance record

Decision date
Received
(86 days to decision)
Product code
LQW Test, Temperature Discrimination
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Applicant
Sensortek, Inc. 154 Huron Ave., Clifton NJ
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