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FDA PMA

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

PMA Number: P200031 · 2026-05-13

ApplicantTransMedics, Inc.
Decision Date2026-05-13
PMA NumberP200031
Product CodeQQK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is a medical device manufactured by TransMedics, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-13 under PMA number P200031. The device is classified under FDA product code QQK. It was reviewed by the GU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is a medical device that received FDA Premarket Approval (PMA) on 2026-05-13. It is manufactured by TransMedics, Inc.. The PMA number is P200031.

When did Normothermic machine perfusion system for the preservation of donor livers prior to transplantation receive FDA PMA approval?

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation received FDA PMA approval on 2026-05-13, under approval number P200031.

What company makes Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is manufactured by TransMedics, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

The FDA product code for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is QQK.

What FDA device class is Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is classified as Class III by the FDA.

Other Devices by TransMedics, Inc.

PMA P160013Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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