Traferox Technologies, Inc.: FDA clearances and approvals
Traferox Technologies, Inc. has 4 FDA 510(k) clearances (first 2024, latest 2026), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time: 122 days. Since 2017 its median was 122 days, against 143 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 264 |
| 2025 | 1 | 135 |
| 2026 | 2 | 105 |
Review time against the same product codes
Since 2017, Traferox Technologies, Inc.'s cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | 3 | 3 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 1 | 1 |
| PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | 1 | 0 |
Review panels
Most recent Traferox Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261913 | X°Port Heart Preservation System | MSB | 2026-09-16 | 100 |
| K260456 | VI°Port Liver Preservation System | KDN | 2026-06-01 | 110 |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | KDN | 2025-05-01 | 135 |
| K240650 | LungProtect | KDN | 2024-11-26 | 264 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250025 | PMA | TorEx Lung Perfusion System | 2026-07-15 |
Recalls
openFDA lists no recalls under a recalling firm named Traferox Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Traferox Technologies, Inc. have?
Traferox Technologies, Inc. has 4 FDA 510(k) clearances (first 2024, latest 2026), plus 1 PMA decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Traferox Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Traferox Technologies, Inc.'s cleared 510(k)s is 122 days. Since 2017: 122 days, versus 143 days for all cleared 510(k)s in the same product codes.
What devices does Traferox Technologies, Inc. make?
Its most frequent FDA product codes are KDN (System, Perfusion, Kidney, 3); MSB (System And Accessories, Isolated Heart, Transport And Preservation, 1); PHO (Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs, 1).
Has Traferox Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Traferox Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 4 Traferox Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDN, Traferox Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.