Ultrox True Membrane Oxygenator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Scimed Ultrox True Membrane Oxy. Ultrox I & II

510(k) Number

K883054 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Scimed Viper

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  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

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  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

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  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

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  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

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  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the Ultrox True Membrane Oxygenator I & II used for?

  The Ultrox True Membrane Oxygenator I & II is a Class II medical device designed specifically for gas exchange during extracorporeal circulation. It oxygenates blood and removes carbon dioxide during cardiac or vascular surgeries requiring cardiopulmonary bypass, ensuring safe perfusion support throughout the procedure. Its membrane-based technology enables efficient and reliable blood oxygenation in controlled clinical settings like operating rooms or cardiac catheterization labs.

• How is the Ultrox True Membrane Oxygenator I & II supplied and intended for use?

  The device is supplied sterile and packaged for single-use only, adhering to strict clinical standards. It is not intended for reuse or repeated use in different patients. This ensures patient safety and maintains the device’s performance and sterility. The manufacturer provides guidelines for storage and handling to preserve functionality and sterility until use in a controlled clinical environment.

• Is the Ultrox True Membrane Oxygenator I & II compatible with MRI environments?

  No, the Ultrox True Membrane Oxygenator I & II is explicitly not intended for use in MRI environments. Its design and materials are not optimized for magnetic resonance imaging compatibility, which could pose risks to both the device and the patient during such procedures. Always verify the clinical setting’s equipment and protocols before use.

• What regulatory clearance does the Ultrox True Membrane Oxygenator I & II hold?

  The device holds FDA 510(k) clearance under the product code DTZ, regulated under 21 CFR 870.4350. The clearance was granted as substantially equivalent to a predicate device, following a traditional review process by the FDA’s Cardiovascular (CV) Advisory Committee. This classification ensures it meets U.S. safety and performance standards for cardiopulmonary bypass oxygenators.

• What models or variants of the Ultrox True Membrane Oxygenator I & II are available?

  The Ultrox True Membrane Oxygenator is available in two distinct variants: Ultrox I and Ultrox II. While both share the same core membrane-based oxygenation technology, their specific design features (e.g., flow rates, priming volumes, or membrane surface area) may differ to accommodate varying clinical needs. Always confirm the correct model with the manufacturer or product documentation to ensure compatibility with your cardiopulmonary bypass circuit and patient requirements.