When did TorEx Lung Perfusion System; TorEx Lung Perfusate receive FDA clearance or approval?

TorEx Lung Perfusion System; TorEx Lung Perfusate (Submission ID: P250025) was fda approved by the U.S. FDA on 2026-10-30 under the PMA pathway with a review duration of 84 days.

Who is the manufacturer or applicant for TorEx Lung Perfusion System; TorEx Lung Perfusate?

The applicant and sponsor for P250025 is Traferox Technologies, Inc..

Is P250025 an AI/ML-enabled medical device?

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Approved Existing Device (Modification) Pathway: PMA

TorEx Lung Perfusion System; TorEx Lung Perfusate

Applicant: Traferox Technologies, Inc.

Statutory Profile

Legal Standard:

Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)

Product Code:

PHO

Review Panel:

Gastroenterology, Urology

21 CFR Regulation:

Unspecified

Review Velocity Metrics

Date Received:

2026-08-07

Decision Date:

2026-10-30

Total Review Duration:

84 calendar days (84 days)

Official FDA Research Backlinks

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

FDA Database Webpage (pmn.cfm) Official Decision Summary PDF Product Classification Database Establishment Registration & Listing

Identified Contacts & Correspondents

Nicole Baker

Role: OFFICIAL_CORRESPONDENT

📞 1-416-7882253-x

Stephan Toupin

Role: US_AGENT

📞 786-7311159

✉️ stoupin@dawamedical.com

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