QUADROX-i
The QUADROX-i Small Adult is a membrane oxygenator for extracorporeal circulation during cardiopulmonary bypass surgery. It adds oxygen, removes carbon dioxide and regulates blood…
The QUADROX-i Small Adult is a membrane oxygenator for extracorporeal circulation during cardiopulmonary bypass surgery. It adds oxygen, removes carbon dioxide and regulates blood temperature within its specified blood flow range of 0.5 to 5 liters per minute.
The HMO 51000 configuration includes an arterial filter that removes air bubbles and particles larger than 40 micrometers. Versions without the filter are also part of the family, and BIOLINE coated configurations are available.
Listed Item
QUADROX-i Small Adult Microporous Membrane Oxygenator with integrated arterial filter, BIOLINE coated, with a screw connector
Duration and System Support
Use is limited to six hours. A compatible holding clamp supports the oxygenator as part of the system arrangement. Selection and operation occur within the cardiac surgical bypass circuit under the attending physician’s direction.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K132829 |
| Record published | 2015-10-24 |
| Record revised | 2020-02-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4 |
| Sizes | Total volume 295 to 335 ml |
| Distribution end date | 2024-09-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BEQ-HMO 50000-USA #SQUADR-i Small Ado.Fi / Small Adult, BIOLINE | In distribution | |
| Adult | Withdrawn | |
| Adult | Withdrawn | |
| HMO 50000-USA #SQUADROX-i Small Adult, no Filter | Withdrawn | |
| HMO 71000-USA #SQUADROX-i Adult + Coating, Filter | Total Volume 335 ml | Withdrawn |
| BEQ-HMO 51000 #SQUADR-i Small Adult +Fi. / Small Adult, Filter; BIOLINE Coating | Total Volume 295 ml | Withdrawn |
| Adult, Filter; BIOLINE Coating | Total Volume 335 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. | Terumo Cardiovascular Systems Corporation | 6 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150267 | 2015-05-07 |
| K132829 | 2013-10-08 |
| K112360 | 2011-09-15 |
| K103191 | 2011-03-08 |
| K102464 | 2011-03-04 |
| K101153 | 2010-12-08 |
| K100278 | 2010-04-30 |
| K093522 | 2009-12-07 |
| K090689 | 2009-10-29 |
| K090511 | 2009-06-12 |
| K082117 | 2009-02-18 |
| K071774 | 2008-01-23 |
| K061628 | 2006-08-22 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Maquet Medical Systems, Usa | 510(k) number | 2023-05-18 | Class II | Pending | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory’s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barri | 1,784 (US) | |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2016-02-23 | Class II | Unknown/Undetermined by firm | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. | 72,000 units in total | 2019-09-25 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2015-03-05 | Class II | Nonconforming Material/Component | A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set | 10,199 units | 2019-01-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.
Records are records: nothing here is an offer of sale.