Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAC — Predicate Candidate Screening
195 FDA 510(k) clearances under this product code; the 50 most recent screened below.
101 daysmedian FDA review time
333 days90th percentile
195clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024-08-16 | 106 | 0 |
| K240426 | Aventus Clot Management System | Inquis Medical | 2024-05-14 | 91 | 0 |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | 2024-04-29 | 59 | 0 |
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | 2023-07-14 | 28 | 0 |
| K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023-02-17 | 270 | 0 |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System ( | Haemonetics Corporation | 2022-11-15 | 154 | 0 |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest | Atrium Medical Corporation | 2021-09-03 | 476 | 4 |
| K210862 | Hemafuse System | Sisu Global Health | 2021-07-29 | 128 | 0 |
| K210176 | FlowSaver Blood Filter | Inari Medical | 2021-07-22 | 181 | 0 |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Fresenius Kabi AG | 2021-02-11 | 29 | 0 |
| K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. | 2020-06-01 | 180 | 0 |
| K192368 | CATSmart | Fresenius Kabi AG | 2019-09-27 | 28 | 0 |
| K180831 | CATSmart | Fresenius Kabi AG | 2018-12-10 | 255 | 0 |
| K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | 2018-08-22 | 30 | 0 |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | 2017-01-03 | 126 | 0 |
| K160735 | CATSmart | Fresenius Kabi AG | 2016-09-16 | 183 | 0 |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | 2016-05-24 | 118 | 0 |
| K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFU | Teleflexmedical, Inc. | 2014-10-23 | 269 | 0 |
| K140197 | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SY | Teleflexmedical, Inc. | 2014-10-21 | 267 | 0 |
| K131553 | XTRA | Sorin Group Deutschland GmbH | 2014-03-21 | 295 | 0 |
| K130043 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION | Teleflexmedical, Inc. | 2013-02-12 | 35 | 0 |
| K120953 | PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION | Tlelflex Medical, Inc. | 2012-12-10 | 255 | 0 |
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Haemonetics Corp. | 2012-10-25 | 90 | 0 |
| K120586 | CELL SAVER ELITE | Haemonetics Corp. | 2012-05-22 | 85 | 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 |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | Haemonetics Corp. | 2010-12-03 | 148 | 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 |
| K093535 | AUTOLOG AUTOTRANSFUSION SYSTEM | Medtronic, Inc. | 2010-03-22 | 126 | 0 |
| K082923 | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C | Life-Tech, Inc. | 2008-10-24 | 23 | 0 |
| K060482 | CYTORI CELUTION CELL CONCENTRATION DEVICE | Cytori Therapeutics, Inc. | 2006-09-28 | 217 | 0 |
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYS | Haemonetics Corp. | 2005-11-21 | 27 | 3 |
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYS | Haemonetics Corp. | 2005-01-04 | 53 | 1 |
| K043140 | EXPRESS AND OASIS CHEST DRAIN | Atrium Medical Corp. | 2004-12-08 | 23 | 20 |
| K041525 | HEMOVAC BLOOD REINFUSION SYSTEM | Zimmer, Inc. | 2004-10-14 | 128 | 0 |
| K031554 | S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRAN | Genzyme Biosurgery | 2003-07-25 | 67 | 0 |
| K022167 | PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REI | Pall Corp. | 2003-03-07 | 247 | 0 |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION S | Summit Medical , Ltd. | 2003-02-14 | 64 | 0 |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION S | Summit Medical , Ltd. | 2002-10-09 | 72 | 0 |
| K020647 | DIDECO ELECTA | Dideco S.P.A. | 2002-09-05 | 189 | 2 |
| K022348 | ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABL | Interpore Cross Intl. | 2002-08-15 | 27 | 0 |
| K012406 | ACCESS SEQUESTRATION SYSTEM | Interpore Cross Intl. | 2002-03-26 | 239 | 0 |
| K014187 | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM | Boehringer Laboratories | 2002-02-06 | 47 | 0 |
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | Haemonetics Corp. | 2002-01-08 | 28 | 2 |
| K012178 | FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUE | Fresenius Hemotechnology, Inc. | 2001-07-23 | 11 | 1 |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONET | Haemonetics Corp. | 1999-11-18 | 27 | 0 |
| K992723 | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | Transfusion Technologies Corp. | 1999-10-18 | 66 | 1 |
| K991986 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LI | Cobe Cardiovascular, Inc. | 1999-09-09 | 87 | 0 |
| K983022 | SMARTCELL PROCESSING SYSTEM | Harvest Technologies, LLC | 1999-04-02 | 214 | 0 |
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