Eurosets S.R.L: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Eurosets S.R.L” (first 2011, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 246 days. Since 2017 the median was 269 days, against 124 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 246 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 352 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 364 |
| 2026 | 1 | 137 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eurosets S.R.L took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Eurosets S.R.L 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | DTZ | 2026-09-14 | 137 |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | DTZ | 2025-12-12 | 269 |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | DTZ | 2025-11-24 | 459 |
| K202510 | AMG PMP Infant | DTZ | 2021-12-10 | 466 |
| K202206 | AMG PMP Pediatric | DTZ | 2021-04-01 | 239 |
| K141492 | ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) | DTZ | 2015-02-06 | 246 |
| K102109 | ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 | DTZ | 2011-02-15 | 202 |
Recalls
openFDA lists no recalls under a recalling firm named Eurosets S.R.L.
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 Eurosets S.R.L is the lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07354841: Safety and Performance Evaluation of CPB Venous and Arterial Cannulas (Recruiting, started 2025-10-21)
- NCT07087639: Novel Venous Cannula Trial (Completed, started 2022-12-22)
- NCT05163925: EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications (Recruiting, started 2022-01-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eurosets S.R.L?
FDA lists 7 510(k) clearances under the applicant name “Eurosets S.R.L” (first 2011, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eurosets S.R.L?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eurosets S.R.L is 246 days. Since 2017: 269 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eurosets S.R.L?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 7).
Next steps
- See all 7 Eurosets S.R.L clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Eurosets S.R.L'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.