Chrysalis Intelligence · Sponsors · TransMedics, Inc.

TransMedics, Inc.

Andover, MA, US · 3 510(k) clearances · 35 PMAs

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Total clearances
3
2021-07-29 → 2023-10-31
Last 12 months
0
Product codes
2
Most recent
2023-10-31
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MSB System And Accessories, Isolated Heart, Transport And Preservation Class II Gastroenterology, Urology 2 2022-11-18
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Class II Cardiovascular 1 2023-10-31
Class III

PMA approvals (35)

Total PMA records
35
Originals + supplements
Distinct product codes
3
First decision
2020-12-03
Most recent
2026-05-13
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-13 P200031-S013 Organ Care System (OCS™) Liver Real-Time Process QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2026-05-13 P160013-S021 Organ Care System (OCS™) Lung System Real-Time Process QBA — —
2026-03-09 P200031-S014 Organ Care System (OCS™) Liver Normal 180 Day Track No User Fee QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2025-12-16 P200031-S012 Organ Care System™ (OCS™) Liver Special (Immediate Track) QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2025-12-16 P180051-S009 Organ Care System™ (OCS™) Heart Special (Immediate Track) QIK Organ Care System (Ocs) Heart System Unknown
2025-12-16 P160013-S020 Organ Care System™ (OCS™) Lung System Special (Immediate Track) QBA — —
2025-10-22 P200031-S011 Organ Care System™ (OCS™) Liver 30-Day Notice QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2025-10-22 P180051-S008 Organ Care System™ (OCS™) Heart System 30-Day Notice QIK Organ Care System (Ocs) Heart System Unknown
2025-10-22 P160013-S019 Organ Care System™ (OCS™) Lung System 30-Day Notice QBA — —
2025-07-01 P200031-S010 Organ Care System™ (OCS™) Liver Real-Time Process QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2025-01-13 P200031-S007 Organ Care System (OCS™) Liver Normal 180 Day Track QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2024-10-23 P180051-S007 Organ Care System (OCS) Heart System 30-Day Notice QIK Organ Care System (Ocs) Heart System Unknown
2024-10-11 P200031-S009 Organ Care System™ (OCS™) Liver 30-Day Notice QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2024-10-11 P180051-S006 Organ Care System™ (OCS™) Heart 30-Day Notice QIK Organ Care System (Ocs) Heart System Unknown
2024-10-11 P160013-S018 Organ Care System™ (OCS™) Lung 30-Day Notice QBA — —
2024-02-23 P200031-S006 Organ Care System (OCS®) Liver™ Normal 180 Day Track No User Fee QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2024-01-09 P160013-S016 Organ Care System (OCS™) Lung System Normal 180 Day Track No User Fee QBA — —
2023-06-28 P200031-S004 Organ Care System™ (OCS™) Liver 30-Day Notice QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2023-06-28 P180051-S004 Organ Care System™ (OCS™) Heart 30-Day Notice QIK Organ Care System (Ocs) Heart System Unknown
2023-06-28 P160013-S014 Organ Care System™ (OCS™) Lung 30-Day Notice QBA — —
2023-06-28 P160013-S013 Organ Care System (OCS™) Lung System Normal 180 Day Track No User Fee QBA — —
2023-05-09 P200031-S003 Organ Care System (OCS™) Liver Real-Time Process QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2023-05-09 P180051-S003 Organ Care System (OCS) Heart System Real-Time Process QIK Organ Care System (Ocs) Heart System Unknown
2023-05-09 P160013-S012 Organ Care System (OCS™) Lung System Real-Time Process QBA — —
2023-02-24 P160013-S010 Organ Care System (OCS™) Lung System Normal 180 Day Track No User Fee QBA — —
2023-02-23 P200031-S002 Organ Care System (OCS™) Liver 30-Day Notice QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2023-02-23 P180051-S002 Organ Care System (OCS) Heart 30-Day Notice QIK Organ Care System (Ocs) Heart System Unknown
2023-02-23 P160013-S011 Organ Care System (OCS™) Lung 30-Day Notice QBA — —
2022-09-19 P200031-S001 Organ Care System (OCS®) Liver™ Normal 180 Day Track No User Fee QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2022-05-06 P160013-S009 Organ Care System™ (OCS) Lung System Real-Time Process QBA — —
2022-04-27 P180051-S001 OCS Heart System Panel Track QIK Organ Care System (Ocs) Heart System Unknown
2021-09-28 P200031 Organ Care System (OCS™) Liver Original QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown
2021-09-03 P180051 Organ Care System (OCS) Heart System Original QIK Organ Care System (Ocs) Heart System Unknown
2021-08-02 P160013-S008 Organ Care System (OCS™) Lung System Real-Time Process QBA — —
2020-12-03 P160013-S007 Organ Care System (OCS) Lung System Real-Time Process QBA — —
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2023-10-31 K231362 OCS Heart Leukocyte Depleting Filter DTM Class II Cardiovascular
2022-11-18 K222535 OCS Lung Donor Flush Set MSB Class II Gastroenterology, Urology
2021-07-29 K211314 OCS Lung Solution MSB Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence