Venture IHO 100 Home Fill Complete Home Oxygen System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K983627 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)
The Venture IHO 100 Home Fill Complete Home Oxygen System is a portable oxygen generator designed to provide supplemental oxygen therapy for patients with respiratory conditions. It functions as a home-based oxygen source, converting ambient air into concentrated oxygen and compressing it into portable cylinders for patient use.
This system is intended for use in home settings by patients or caregivers and operates as a complete home oxygen solution. It includes a stationary oxygen concentrator for refilling portable cylinders, with no explicit regulatory status stated beyond FDA 510(k) clearance under the Anesthesiology advisory committee. The device is classified as Class II and regulated under 21 CFR 868.5440, with no indication of sterility or single-use requirements.
Frequently asked questions
What is the primary purpose of the Venture IHO 100 Home Fill Complete Home Oxygen System, and how does it differ from traditional oxygen therapy methods?
The Venture IHO 100 is designed as a complete home oxygen solution for patients with respiratory conditions, eliminating the need for pre-filled oxygen cylinders. Unlike traditional methods that rely on canisters or tanks filled by external suppliers, this system converts ambient air into concentrated oxygen and compresses it into portable cylinders at home. This makes it ideal for continuous or on-demand oxygen therapy in residential settings, ensuring a steady supply without frequent refills.
Is the device intended for single-use or repeated use, and how should the portable cylinders be managed?
The system is not single-use—it is built for repeated use in home settings. The stationary oxygen concentrator refills portable cylinders on-site, allowing patients or caregivers to maintain a consistent oxygen supply. While the concentrator itself is reusable, the portable cylinders may require periodic replacement based on manufacturer guidelines, though the data does not specify a single-use requirement for them.
What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?
The Venture IHO 100 received FDA 510(k) clearance under the Anesthesiology advisory committee (AN), with a decision dated October 22, 1999. The device was classified as substantially equivalent (SESE) to a predicate product, and its regulatory classification is Class II under 21 CFR 868.5440, which governs oxygen generators. This pathway ensures compliance with safety and performance standards for home-use oxygen systems.
How is the device supplied, and are there different models or sizes available?
The system is supplied as a complete home oxygen solution, including a stationary oxygen concentrator and portable cylinders for refilling. While the data does not specify exact cylinder sizes or additional models, the OpenFDA registration numbers indicate multiple FEI (Facility Establishment Identifier) records, suggesting potential variations in cylinder capacity or system configurations. For precise sizing, refer to the manufacturer’s technical documentation or contact Invacare Corp.
Does the device require any special storage conditions, and is sterility a concern for the portable cylinders?
The data does not specify sterility requirements for the portable cylinders, as the system is not described as a sterile medical device. However, standard home-use oxygen equipment should be stored in a dry, well-ventilated area, away from direct sunlight or extreme temperatures. The stationary concentrator and cylinders should follow manufacturer instructions for optimal performance and safety, though no explicit storage guidelines are provided in the regulatory records.
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: Venture Iho 100 Home Fill Complete Home Oxygen System, INVACARE HOMEFILL OXYGEN SYSTEM USER MANUAL Pdf Download, Invacare Homefill Oxygen System User Manual - MedCare, Invacare HomeFill Oxygen System Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983627 | Class II | Active |
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Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA 510(k) K983627 24 fields · synced Sep 19, 2026