Sorin Group Italia S.R.L.: FDA clearances and approvals
Sorin Group Italia S.R.L. has 61 FDA 510(k) clearances (first 1995, latest 2026), across 10 product codes in 2 review panels. Median 510(k) review time: 76 days. Since 2017 its median was 112 days, against 126 days for all cleared 510(k)s in the same product codes. openFDA lists 6 product recalls by a recalling firm named Sorin Group Italia S.R.L.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 90 |
| 2013 | 3 | 27 |
| 2014 | 1 | 17 |
| 2015 | 2 | 120 |
| 2016 | 0 | — |
| 2017 | 2 | 285 |
| 2018 | 3 | 30 |
| 2019 | 2 | 86 |
| 2020 | 3 | 88 |
| 2021 | 1 | 60 |
| 2022 | 0 | — |
| 2023 | 2 | 191 |
| 2024 | 5 | 86 |
| 2025 | 5 | 129 |
| 2026 | 1 | 70 |
Review time against the same product codes
Since 2017, Sorin Group Italia S.R.L.'s cleared 510(k)s took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 22 | 22 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 12 | 12 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 8 | 8 |
| CAC | Apparatus, Autotransfusion | 6 | 6 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 6 | 6 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | 2 |
| KRH | Ring, Annuloplasty | 2 | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 | 1 |
Review panels
Most recent Sorin Group Italia S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253671 | Dual Stage Venous Cannulae | DWF | 2026-01-30 | 70 |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | DTN | 2025-12-22 | 194 |
| K253616 | ProtekDilate Vascular Access Kit | DRE | 2025-12-19 | 31 |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | DWF | 2025-06-27 | 119 |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | DTR | 2025-05-30 | 129 |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | KDI | 2025-04-25 | 192 |
| K242953 | KIDS Arterial Filters | DTM | 2024-12-20 | 86 |
| K242092 | MICRO Arterial Filters | DTM | 2024-11-18 | 124 |
| K241236 | XTRA Collection sets; XTRA Sequestration set X | CAC | 2024-08-16 | 106 |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | CAC | 2024-04-29 | 59 |
51 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-07-29.
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 Sorin Group Italia S.R.L. have?
Sorin Group Italia S.R.L. has 61 FDA 510(k) clearances (first 1995, latest 2026), across 10 product codes in 2 review panels.
How long does FDA take to clear Sorin Group Italia S.R.L.'s 510(k)s?
The median time from FDA receipt to decision across Sorin Group Italia S.R.L.'s cleared 510(k)s is 76 days. Since 2017: 112 days, versus 126 days for all cleared 510(k)s in the same product codes.
What devices does Sorin Group Italia S.R.L. make?
Its most frequent FDA product codes are DTZ (Oxygenator, Cardiopulmonary Bypass, 22); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 12); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 8).
Has Sorin Group Italia S.R.L. had device recalls?
openFDA lists 6 product recalls in 2 recall events by a recalling firm whose name matches Sorin Group Italia S.R.L; the most recent began 2020-07-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 61 Sorin Group Italia S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Sorin Group Italia S.R.L.'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.