# K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Feb 18, 2009 after 205 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922933 (1992). 14 ancestors in all.
21 later devices descend from it; 12 cite it directly.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030264: Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030, Jostra AG (2003) Summary page 1.
- K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi, Sorin Group Italia S.R.L. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K001787: Quart Arterial Filter, Model HBF 140, Jostra Medizintechnik AG (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000 (2009), 12 descendants of its own
- K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C (2009), 8 descendants of its own
- K101153: Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod 70000-Usa, Beq-Hmod 70000-Usa, Hmod (2010), 6 descendants of its own
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators (2013), 4 descendants of its own
- K090533: HLM Tubing Set with Softline Coating (2009), 3 descendants of its own

## Recalls of this device
- May 18, 2023 · Class II · Z-1659-2023: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, 
- May 18, 2023 · Class II · Z-1638-2023: 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 i
- Feb 23, 2016 · Class II · Z-1371-2016: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
- Aug 15, 2013 · Class II · Z-2262-2013: The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond
- Jun 12, 2012 · Class II · Z-0160-2013: It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,0

## Indications for use
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 pm. The device's utilization period is limited to six hours. The oxygenator is suitable for the delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

Source page: https://510kreport.com/device/K082117
Methodology: https://510kreport.com/methodology