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The Tracker / June 2026 / P240033

PMA approved

LungFX device

Lung Bioengineering, Inc. · Jun 22, 2026 · P240033

FDA approved the LungFX device from Lung Bioengineering, Inc. on Jun 22, 2026 under P240033, an original premarket approval. The device falls under product code PHO, Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 30, 2024. The decision came 630 days later.

This is the only decision on file for Lung Bioengineering, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P240033?

P240033 is the FDA PMA for LungFX device, submitted by Lung Bioengineering, Inc.. FDA's decision date was Jun 22, 2026, under product code PHO (Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs).

Who makes the LungFX device?

Lung Bioengineering, Inc., based in Silver Spring, MD, is the applicant of record for P240033.

How long did the P240033 review take?

FDA received the submission on Sep 30, 2024 and issued its decision on Jun 22, 2026, 630 days later.

← All decisions in June 2026