Company ยท IT
Sorin Group Italia S.R.L.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (5 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 22 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 14 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 8 |
| CAC | Apparatus, Autotransfusion | 6 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 6 |
| LWR | Heart-Valve, Non-Allograft Tissue | 5 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 |
| KRH | Ring, Annuloplasty | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 |
| LNX | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2026 | K263092 | Dual Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Sep 28, 2026 | K262052 | Tri Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Jan 30, 2026 | K253671 | Dual Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Dec 22, 2025 | K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs Sorin Group Italia S.R.L., IT | DTN |
| Dec 19, 2025 | K253616 | ProtekDilate Vascular Access Kit Sorin Group Italia S.R.L., IT | DRE |
| Jun 27, 2025 | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) Sorin Group Italia S.R.L., IT | DWF |
| May 30, 2025 | K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard Sorin Group Italia S.R.L., IT | DTR |
| Apr 25, 2025 | K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) Sorin Group Italia S.R.L., IT | KDI |
| Dec 20, 2024 | K242953 | KIDS Arterial Filters Sorin Group Italia S.R.L., IT | DTM |
| Nov 18, 2024 | K242092 | MICRO Arterial Filters Sorin Group Italia S.R.L., IT | DTM |
| Aug 16, 2024 | K241236 | XTRA Collection sets; XTRA Sequestration set X Sorin Group Italia S.R.L., IT | CAC |
| Apr 29, 2024 | K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) Sorin Group Italia S.R.L., IT | CAC |
| Feb 22, 2024 | K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) Sorin Group Italia S.R.L., IT | DWF |
| Nov 16, 2023 | K231652 | D100 KIDS; D101 KIDS Sorin Group Italia S.R.L., IT | DTZ |
| Jun 10, 2023 | K223361 | BMR 1900 PHISIO Sorin Group Italia S.R.L., IT | DTN |
| Jul 12, 2021 | K211495 | EOS PMP Sorin Group Italia S.R.L., IT | DTZ |
| Nov 17, 2020 | K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line Sorin Group Italia S.R.L., IT | DWF |
| Aug 13, 2020 | K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator Sorin Group Italia S.R.L., IT | DTZ |
| Jun 12, 2020 | K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated Sorin Group Italia S.R.L., IT | DTZ |
| Aug 7, 2019 | K190650 | Revolution Centrifugal Blood Pump Sorin Group Italia S.R.L., IT | KFM |
| Apr 13, 2019 | K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygena Sorin Group Italia S.R.L., IT | DTZ |
| Nov 16, 2018 | K180979 | PureFlex Arterial Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Mar 16, 2018 | K180411 | MEMO 4D Sorin Group Italia S.R.L., IT | KRH |
| Mar 15, 2018 | K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hol Sorin Group Italia S.R.L., IT | DTZ |
| Jun 16, 2017 | K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Mar 8, 2017 | K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C Sorin Group Italia S.R.L., IT | DTN |
| Nov 6, 2015 | K151713 | LILLIPUP PMP, LILLIPUT PMP INTEGRATED Sorin Group Italia S.R.L., IT | DTZ |
| Jun 11, 2015 | K150489 | EOS PMP, EOS PMP Integrated Sorin Group Italia S.R.L., IT | DTZ |
| Aug 29, 2014 | K142221 | MEMO 3D ReChord Sorin Group Italia S.R.L., IT | KRH |
| Jun 6, 2013 | K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR Sorin Group Italia S.R.L. | DTN |
| Mar 20, 2013 | K130433 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE Sorin Group Italia S.R.L. | DTZ |
| Feb 12, 2013 | K130209 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED Sorin Group Italia S.R.L. | DTZ |
| Oct 17, 2012 | K122844 | INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR Sorin Group Italia S.R.L. | DTZ |
| Aug 24, 2012 | K122254 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR Sorin Group Italia S.R.L. | DTZ |
| Aug 22, 2012 | K121536 | INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR Sorin Group Italia S.R.L. | DTZ |
| Jul 26, 2012 | K121909 | INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR Sorin Group Italia S.R.L. | DTZ |
| Jul 23, 2012 | K121229 | INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY Sorin Group Italia S.R.L. | DTZ |
| May 11, 2012 | K120185 | INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR Sorin Group Italia S.R.L. | DTZ |
| Apr 5, 2012 | K113626 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR Sorin Group Italia S.R.L. | DTZ |
| Oct 14, 2011 | K112771 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG Sorin Group Italia S.R.L. | DTN |
| Sep 6, 2011 | K112245 | XTRA Sorin Group Italia S.R.L. | CAC |
| Apr 7, 2011 | K110782 | XVAC Sorin Group Italia S.R.L. | CAC |
| Nov 23, 2010 | K103202 | PREASSEMBLED SURGICAL WASH SET Sorin Group Italia S.R.L. | CAC |
| Oct 5, 2010 | K101586 | XTRA AUTOTRANSFUSION SYSTEM Sorin Group Italia S.R.L. | CAC |
| Mar 24, 2010 | K100507 | XRES BLOOD COLLECTION RESERVOIR Sorin Group Italia S.R.L. | DTN |
| Jan 22, 2010 | K093986 | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS Sorin Group Italia S.R.L. | DTM |
| Dec 18, 2009 | K093601 | AF 840 PH.I.S.I.O. ARTERIAL FILTER Sorin Group Italia S.R.L. | DTM |
| Oct 19, 2009 | K092895 | APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Sorin Group Italia S.R.L. | DTZ |
| Aug 12, 2009 | K092315 | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR Sorin Group Italia S.R.L. | DTN |
| Nov 19, 2008 | K081313 | SH14 HEMOCONCENTRATOR Sorin Group Italia S.R.L. | KDI |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to redu Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used t Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to Terminated |
LWR | None listed |
| Jul 29, 2020 | Sorin Group Italia S.r.l. Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used Terminated |
LWR | None listed |
| Jan 22, 2014 | Sorin Group Italia S.r.l. ORCHESTRA/ORCHESTRA PLUS Programmer Terminated |
LNX | None listed |