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Venture Homefill II With Oxygen Conserver

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021685

by Invacare Corp.

Identifiers

510(k) Number
K021685 FDA 510(k)
FDA Product Code
CAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5440 FDA 510(k)
Regulation Number
868.5440 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a portable oxygen generator designed to compress oxygen from specially equipped Invacare concentrators into oxygen cylinders for patient use. It enables ambulatory oxygen supply by allowing patients to refill cylinders at home, providing a convenient and safe method for oxygen therapy without reliance on external delivery services.

The Venture Homefill II With Oxygen Conserver is supplied as a reusable system for home use, requiring connection to an oxygen concentrator and appropriate cylinders. It is not sterile and is intended for repeated use under normal operating conditions. The device has received FDA 510(k) clearance (K021685) and is classified as a Class II medical device under regulation number 868.5440, with product code CAW.

Frequently asked questions

What is the Venture Homefill II With Oxygen Conserver used for?

It is used to compress oxygen from specially equipped Invacare oxygen concentrators into oxygen cylinders, allowing patients to refill their own cylinders at home for ambulatory oxygen therapy without relying on external delivery services.

Is the Venture Homefill II With Oxygen Conserver sterile or single-use?

The device is not sterile and is designed for repeated use under normal operating conditions; it is supplied as a reusable system for home use, requiring connection to an oxygen concentrator and appropriate cylinders.

What regulatory clearance does the Venture Homefill II With Oxygen Conserver have?

The device has received FDA 510(k) clearance under number K021685 and is classified as a Class II medical device under regulation 868.5440 with product code CAW.

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: PDF HomeFill II - Invacare Resource Center, PDF 510(k) SUMMARY Invacare Corporation's Model Venture HomeFill II With ..., Invacare Venture HomeFill II Owner's Operator And ... - ManualsLib, VENTURE HOMEFILL II WITH OXYGEN CONSERVER (K021685) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Invacare Corp.

Sources (1)

  • FDA 510(k) K021685 24 fields · synced Sep 21, 2026