Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Haemonetics Corp. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
205 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Haemonetics Corp. | 2012-10-25 | 90 | 0 |
| K120586 | CELL SAVER ELITE | Haemonetics Corp. | 2012-05-22 | 85 | 0 |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | Haemonetics Corp. | 2010-12-03 | 148 | 0 |
| K062801 | SMARTSUCTION SOLO DEVICE | Haemonetics Corp. | 2006-10-04 | 15 | 0 |
| K061103 | HAEMONETICS 40U RBC FILTER BAG | Haemonetics Corp. | 2006-05-17 | 27 | 0 |
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYS | Haemonetics Corp. | 2005-11-21 | 27 | 3 |
| K052626 | SMARTSUCTION HARMONY DEVICE | Haemonetics Corp. | 2005-10-05 | 12 | 1 |
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYS | Haemonetics Corp. | 2005-01-04 | 53 | 1 |
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | Haemonetics Corp. | 2002-01-08 | 28 | 2 |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONET | Haemonetics Corp. | 1999-11-18 | 27 | 0 |
| K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | Haemonetics Corp. | 1996-06-04 | 302 | 0 |
| K944232 | AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS | Haemonetics Corp. | 1995-07-20 | 322 | 0 |
| K932890 | CELL SAVER 5 SYSTEM | Haemonetics Corp. | 1994-01-05 | 205 | 6 |
| K904474 | HAEMONETICS LN 200F COLLECTION RESERVOIR | Haemonetics Corp. | 1990-11-13 | 43 | 0 |
| K904041 | HAEMONETICS CELL SAVER 4 PLUS | Haemonetics Corp. | 1990-11-13 | 70 | 0 |
| K893394 | ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR | Haemonetics Corp. | 1989-10-19 | 171 | 0 |
| K883934 | CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM | Haemonetics Corp. | 1988-12-27 | 103 | 0 |
| K872895 | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | Haemonetics Corp. | 1988-01-11 | 172 | 0 |
| K860969 | FLUID MANAGEMENT SYSTEM (MODIFIED) | Haemonetics Corp. | 1986-05-06 | 56 | 0 |
| K852645 | FLUID MANAGEMENT SYSTEM | Haemonetics Corp. | 1985-12-09 | 171 | 0 |
| K852425 | CELL SAVER SUCTION SYSTEM | Haemonetics Corp. | 1985-09-03 | 88 | 0 |
| K811449 | HAEMONETICS 1000ML COMPONENT BAG | Haemonetics Corp. | 1981-07-01 | 40 | 0 |
| K810711 | HAEMONETICS 600 ML. COMPONENT BAG | Haemonetics Corp. | 1981-05-08 | 52 | 0 |
| K810365 | HAEMONETICS 170 Y INFUSION SET | Haemonetics Corp. | 1981-03-31 | 47 | 0 |
| K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG | Haemonetics Corp. | 1981-03-31 | 54 | 0 |
| K810076 | PHERESIS NEEDLE ASSEMBLY | Haemonetics Corp. | 1981-03-05 | 51 | 0 |
| K802674 | RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS. | Haemonetics Corp. | 1981-01-08 | 73 | 0 |
| K800358 | Y-TYPE INFUSION SET (2 LEAD) | Haemonetics Corp. | 1980-04-16 | 56 | 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