Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sorin Group Italia S.R.L. · Predicate Candidate Screening
61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
217 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-01-30 | 70 | 0 |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | 2025-12-22 | 194 | 0 |
| K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025-12-19 | 31 | 0 |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | 2025-06-27 | 119 | 0 |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood card | Sorin Group Italia S.R.L. | 2025-05-30 | 129 | 0 |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator | Sorin Group Italia S.R.L. | 2025-04-25 | 192 | 0 |
| K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | 2024-12-20 | 86 | 0 |
| K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | 2024-11-18 | 124 | 0 |
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024-08-16 | 106 | 0 |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | 2024-04-29 | 59 | 0 |
| K240193 | R501 - R502 aortic root cannulae with and without vent line | Sorin Group Italia S.R.L. | 2024-02-22 | 29 | 0 |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | 2023-11-16 | 163 | 0 |
| K223361 | BMR 1900 PHISIO | Sorin Group Italia S.R.L. | 2023-06-10 | 219 | 0 |
| K211495 | EOS PMP | Sorin Group Italia S.R.L. | 2021-07-12 | 60 | 0 |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root | Sorin Group Italia S.R.L. | 2020-11-17 | 253 | 0 |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber | Sorin Group Italia S.R.L. | 2020-08-13 | 34 | 0 |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial | Sorin Group Italia S.R.L. | 2020-06-12 | 88 | 0 |
| K190650 | Revolution Centrifugal Blood Pump | Sorin Group Italia S.R.L. | 2019-08-07 | 147 | 0 |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/ | Sorin Group Italia S.R.L. | 2019-04-13 | 26 | 0 |
| K180979 | PureFlex Arterial Cannulae | Sorin Group Italia S.R.L. | 2018-11-16 | 217 | 0 |
| K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018-03-16 | 29 | 0 |
| K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fibe | Sorin Group Italia S.R.L. | 2018-03-15 | 30 | 0 |
| K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | Sorin Group Italia S.R.L. | 2017-06-16 | 312 | 0 |
| K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | Sorin Group Italia S.R.L. | 2017-03-08 | 258 | 0 |
| K151713 | LILLIPUP PMP, LILLIPUT PMP INTEGRATED | Sorin Group Italia S.R.L. | 2015-11-06 | 134 | 0 |
| K150489 | EOS PMP, EOS PMP Integrated | Sorin Group Italia S.R.L. | 2015-06-11 | 106 | 0 |
| K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014-08-29 | 17 | 0 |
| K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COL | Sorin Group Italia S.R.L. | 2013-06-06 | 48 | 0 |
| K130433 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL | Sorin Group Italia S.R.L. | 2013-03-20 | 27 | 0 |
| K130209 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL R | Sorin Group Italia S.R.L. | 2013-02-12 | 14 | 0 |
| K122844 | INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTE | Sorin Group Italia S.R.L. | 2012-10-17 | 30 | 0 |
| K122254 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL | Sorin Group Italia S.R.L. | 2012-08-24 | 28 | 0 |
| K121536 | INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARD | Sorin Group Italia S.R.L. | 2012-08-22 | 90 | 0 |
| K121909 | INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDS | Sorin Group Italia S.R.L. | 2012-07-26 | 27 | 0 |
| K121229 | INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED | Sorin Group Italia S.R.L. | 2012-07-23 | 90 | 0 |
| K120185 | INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL | Sorin Group Italia S.R.L. | 2012-05-11 | 109 | 0 |
| K113626 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL | Sorin Group Italia S.R.L. | 2012-04-05 | 119 | 0 |
| K112771 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | Sorin Group Italia S.R.L. | 2011-10-14 | 21 | 0 |
| K112245 | XTRA | Sorin Group Italia S.R.L. | 2011-09-06 | 33 | 0 |
| K110782 | XVAC | Sorin Group Italia S.R.L. | 2011-04-07 | 17 | 0 |
| K103202 | PREASSEMBLED SURGICAL WASH SET | Sorin Group Italia S.R.L. | 2010-11-23 | 22 | 0 |
| K101586 | XTRA AUTOTRANSFUSION SYSTEM | Sorin Group Italia S.R.L. | 2010-10-05 | 120 | 0 |
| K100507 | XRES BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | 2010-03-24 | 30 | 0 |
| K093986 | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS | Sorin Group Italia S.R.L. | 2010-01-22 | 29 | 0 |
| K093601 | AF 840 PH.I.S.I.O. ARTERIAL FILTER | Sorin Group Italia S.R.L. | 2009-12-18 | 28 | 0 |
| K092895 | APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Sorin Group Italia S.R.L. | 2009-10-19 | 28 | 1 |
| K092315 | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS R | Sorin Group Italia S.R.L. | 2009-08-12 | 13 | 0 |
| K081313 | SH14 HEMOCONCENTRATOR | Sorin Group Italia S.R.L. | 2008-11-19 | 194 | 0 |
| K083021 | APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Sorin Group Italia S.R.L. | 2008-10-29 | 20 | 2 |
| K073380 | SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRA | Sorin Group Italia S.R.L. | 2008-02-29 | 88 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda