Sidestream Pump Plug-In Module of Component Monitoring System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K943389 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the Sidestream Pump Plug-In Module of Component Monitoring System used for?

  The device is an analyzer designed to measure carbon dioxide in the gaseous phase. It functions as a plug-in module within a component monitoring system, intended for use in clinical settings where respiratory gas analysis is required, based on its classification as a gas analyzer for carbon dioxide.

• How is the Sidestream Pump Plug-In Module supplied and is it reusable?

  The device is supplied as a plug-in module intended for integration into a larger component monitoring system. While the data does not explicitly state single-use or reusable status, its design as a plug-in module for a monitoring system implies it is intended for repeated use within the system, subject to manufacturer guidelines for maintenance and cleaning.

• What regulatory pathway was used for the Sidestream Pump Plug-In Module, and what was the outcome?

  The device received FDA 510(k) clearance under submission K943389 on March 17, 1995, through a traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device, resulting in a Class II classification with product code CCK.

• What advisory committee reviewed the Sidestream Pump Plug-In Module during its 510(k) submission?

  The device was reviewed by the Anesthesiology advisory committee (product code AN), as indicated in the submission data. This committee provides expert input on devices used in anesthesia and respiratory care, which aligns with the device’s function as a carbon dioxide gas analyzer in monitoring systems.

• Where was the Sidestream Pump Plug-In Module manufactured, and what is the manufacturer’s address?

  The device was manufactured by Hewlett-Packard Co., located at 175 Wyman St., P.O. Box 9030, Waltham, MA 02254, United States. This address appears in the submission records as the applicant’s location during the 510(k) process.