Quadrox-I Adult With And Without Integrated Arterial Filter With Softline Coati…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082117 FDA 510(k)
- FDA Product Code
- DTZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4350 FDA 510(k)
- Regulation Number
- 870.4350 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quadrox-I Adult Oxygenator is a membrane oxygenator designed for use in cardiopulmonary bypass procedures. It facilitates gas exchange by oxygenating and decarboxylating blood during extracorporeal circulation, ensuring efficient perfusion support during surgical interventions. Available with and without an integrated arterial filter, it may also incorporate a Softline coating to enhance compatibility with blood components.
This device is intended for single-use in controlled clinical settings, such as operating rooms or cardiac catheterization labs. The Quadrox-I Adult (Model HMO 71000) includes an integrated arterial filter to remove air bubbles and particles larger than 40 micrometers, while both models are compatible with volatile anesthetics like isoflurane and sevoflurane. Supplied sterile and classified as a Class II device under FDA regulations, it adheres to the 510(k) clearance process with a substantially equivalent determination.
Frequently asked questions
What clinical scenarios is the Quadrox-I Adult oxygenator primarily designed for, and how does the integrated arterial filter benefit the patient during use?
The Quadrox-I Adult oxygenator is specifically designed for use in cardiopulmonary bypass procedures during surgical interventions, such as open-heart surgeries. It facilitates gas exchange by oxygenating and decarboxylating blood, ensuring efficient perfusion support. The integrated arterial filter (available in the Model HMO 71000) removes air bubbles and particles larger than 40 micrometers from the bloodstream, reducing the risk of embolic events and improving patient safety during extracorporeal circulation.
Is the Quadrox-I Adult oxygenator compatible with common volatile anesthetics, and if so, which ones are mentioned?
Yes, the Quadrox-I Adult oxygenator is designed to be compatible with volatile anesthetics commonly used in clinical settings. The device is explicitly mentioned to be compatible with isoflurane and sevoflurane, ensuring smooth integration into anesthesia protocols during cardiopulmonary bypass procedures.
How is the Quadrox-I Adult oxygenator supplied, and what are the key considerations for storage and handling?
The Quadrox-I Adult oxygenator is supplied sterile and intended for single-use in controlled clinical environments like operating rooms or cardiac catheterization labs. Since it is single-use, proper storage in a clean, dry environment away from direct sunlight or extreme temperatures is critical to maintain sterility and functionality until use. Always follow manufacturer guidelines for unpacking and preparation to ensure optimal performance.
What are the available models of the Quadrox-I Adult oxygenator, and how do they differ?
The Quadrox-I Adult oxygenator is available in two models: the HMO 70000, which does not include an integrated arterial filter, and the HMO 71000, which includes an integrated arterial filter to remove air bubbles and particles larger than 40 micrometers. Both models may also feature a Softline coating to enhance blood compatibility, but the key distinction lies in the presence or absence of the arterial filter.
What regulatory pathway was followed for the Quadrox-I Adult oxygenator, and what does this mean for its use in clinical practice?
The Quadrox-I Adult oxygenator underwent the FDA’s 510(k) clearance process, with a determination of substantial equivalence to a predicate device. This means it has been evaluated and approved for marketing in the U.S. as a Class II device, adhering to strict regulatory standards for safety and performance. Clinicians can rely on its compliance with FDA requirements, ensuring it meets established benchmarks for oxygenators used in cardiopulmonary bypass procedures.
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: Quadrox-i Adult With and Without Integrated Arterial Filter With ..., PDF QUADROX-i Small Adult and Adult Choose maximum safety., MAQUET QuadroX-i Oxygenator Overview | PDF | Hemodynamics | Blood - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082117 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (1)
- FDA 510(k) K082117 24 fields · synced Oct 6, 2026