510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010031Substantially Equivalent

Nanoduct Neonatal Sweat Analysis System

ELITechGroup Inc, Logan UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010031 is the FDA 510(k) clearance record for NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM, a class II device, cleared for Wescor, Inc. on under FDA product code KTB (Device, Iontophoresis, Specific Uses). FDA records list 32 510(k) clearances for ELITechGroup Inc, from to . As of , FDA records show no recalls naming K010031.

Clearance record

Decision date
Received
(76 days to decision)
Product code
KTB Device, Iontophoresis, Specific Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Wescor, Inc. 459 S. Main, Logan UT
510(k) summary
Statement
Third party review
No

Clearances, product code KTB

Trailing 12 months

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

FDA records show no clearances under product code KTB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KTB, 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