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Newport C250 Air Compressor Model C250

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041406

by Newport Medical Instruments

Identifiers

510(k) Number
K041406 FDA 510(k)
FDA Product Code
BTI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.6250 FDA 510(k)
Regulation Number
868.6250 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Newport C250 Air Compressor Model C250 is a portable air compressor designed to supply a source of clean, oil-free pressurized air at 42 psig for use with specific Newport ventilators, including the E100M, E150, E200, and e500 models. It is classified as a Class II medical device under regulation number 868.6250, with product code BTI, and was determined to be substantially equivalent through the FDA 510(k) process.

The device was manufactured by Newport Medical Instruments and received FDA 510(k) clearance on December 15, 2004, under traditional review, with the anesthesiology advisory committee involved in the review. It is identified by the K-number K041406 and is intended for use in medical settings where pressurized air is required to support ventilator operation, as specified in the device's authorization and specifications.

Frequently asked questions

What is the Newport C250 Air Compressor Model C250 used for?

The Newport C250 Air Compressor Model C250 is designed to supply a source of clean, oil-free pressurized air at 42 psig for use with specific Newport ventilators, including the E100M, E150, E200, and e500 models, as specified in its authorization and specifications.

How is the Newport C250 Air Compressor Model C250 supplied or configured for use?

The Newport C250 Air Compressor Model C250 is a portable air compressor manufactured by Newport Medical Instruments, intended for use in medical settings where pressurized air is required to support ventilator operation, based on its design and intended use as described in the device data.

What regulatory pathway was used for the Newport C250 Air Compressor Model C250?

The Newport C250 Air Compressor Model C250 was determined to be substantially equivalent through the FDA 510(k) process under traditional review, with the anesthesiology advisory committee involved, and received FDA 510(k) clearance on December 15, 2004, under K-number K041406.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEWPORT C250 AIR COMPRESSOR MODEL C250 - Innolitics, NEWPORT C250 AIR COMPRESSOR MODEL C250 510(k) K041406 - fda.report, FDA 510 (k) Applications Submitted by NEWPORT MEDICAL INSTRUMENTS, Newport - MKS Instruments, Newport Medical C250 Air Compressor C250-110/120V- - eBay

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Newport Medical Instruments

Sources (1)

  • FDA 510(k) K041406 24 fields · synced Oct 6, 2026