Nanoduct Neonatal Sweat Analysis System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K010031 ↗

FDA Product Code

KTB

Device Class

Class II

Regulation

21 CFR Part 890.5525

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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• Wescor Sweat.chek Sweat Conductivity Analyzer

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• Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric

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See all devices from Wescor, Inc. →

• What is the purpose of the Nanoduct Neonatal Sweat Analysis System?

  The Nanoduct Neonatal Sweat Analysis System is designed for laboratory diagnosis of cystic fibrosis in newborns. It uses pilocarpine iontophoresis to induce sweat, followed by continuous-flow analysis to provide accurate diagnostic results.

• How is the Nanoduct system supplied and is it single-use?

  The device is supplied as a complete system with electrodes and sensor connected via a single control cable. It is intended for single-use applications, ensuring hygiene and reliability in each diagnostic procedure.

• What are the key features of the Nanoduct system for neonatal use?

  The system is compact and ergonomic, making it suitable for use in the first days of life. Its design facilitates reliable sweat testing in neonatal patients with simplified operation and continuous-flow analysis capabilities.

• What is the regulatory status of the Nanoduct Neonatal Sweat Analysis System?

  The system is regulated under FDA 510K clearance as a Class II device. It received FDA clearance on March 20, 2001, with the decision code SESE, indicating it is substantially equivalent to other devices in its class.