TransMedics, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “TransMedics, Inc.” (first 2021, latest 2023), plus 3 PMA decisions, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 95 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 90 |
| 2022 | 1 | 88 |
| 2023 | 1 | 173 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name TransMedics, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 95 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 2 | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 1 | 1 |
| QBA | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation | 1 | 0 |
| QIK | Organ Care System (Ocs) Heart System | 1 | 0 |
| QQK | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | 1 | 0 |
Review panels
Most recent TransMedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231362 | OCS Heart Leukocyte Depleting Filter | DTM | 2023-10-31 | 173 |
| K222535 | OCS Lung Donor Flush Set | MSB | 2022-11-18 | 88 |
| K211314 | OCS Lung Solution | MSB | 2021-07-29 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200031 | PMA | Organ Care System (OCS) Liver | 2021-09-28 |
| P180051 | PMA | Organ Care System (OCS) Heart System | 2021-09-03 |
| P160013 | PMA | Organ Care System (OCS) Lung System | 2018-03-22 |
Recalls
openFDA lists no recalls under a recalling firm named TransMedics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named TransMedics, Inc. is the lead sponsor of 23 device studies on ClinicalTrials.gov (9 active or recruiting). Most recent:
- NCT07145515: Enhancing Heart Allograft Function With the OCS Heart System Trial (Recruiting, started 2026-01)
- NCT06513091: US National TOP Registry (Recruiting, started 2025-01-23)
- NCT05915299: US National OCS Heart Perfusion (OHP) Registry (Recruiting, started 2023-08-25)
- NCT05940857: US National OCS Liver Perfusion (OLP) Registry (Recruiting, started 2021-10-14)
- NCT05074160: OCS Liver Perfusion (OLP) Post-Approval Registry (Active not recruiting, started 2021-10-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under TransMedics, Inc.?
FDA lists 3 510(k) clearances under the applicant name “TransMedics, Inc.” (first 2021, latest 2023), plus 3 PMA decisions, across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by TransMedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name TransMedics, Inc. is 90 days. Since 2017: 90 days, versus 95 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under TransMedics, Inc.?
The most frequent FDA product codes under this applicant name are MSB (System And Accessories, Isolated Heart, Transport And Preservation, 2); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 1); QBA (Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation, 1).
Next steps
- See all 3 TransMedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSB, TransMedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.