FDA product code QQK: Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

QQK is the FDA product code for normothermic machine perfusion system for the preservation of donor livers prior to transplantation. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under QQK reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for QQK devices, 1 initiated in the last five years.

Definition

The device is intended for machine preservation of donor livers prior to transplantation.

Classification

Recalls for QQK devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-10-15.

Frequently asked questions

What is FDA product code QQK?

QQK is the FDA product code for normothermic machine perfusion system for the preservation of donor livers prior to transplantation. It is a Class III device, reviewed by the Gastroenterology and Urology panel.

What device class is QQK?

Class III. Typical premarket route: PMA.

Have QQK devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-10-15.

Next steps

• Run an FDA pathway report with predicate devices for product code QQK
• Run a recall and safety report across every QQK manufacturer
• Watch product code QQK for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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