Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BRZ — Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
262 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | 2022-11-17 | 262 | 0 |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | 2021-06-10 | 125 | 0 |
| K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | Arteriocyte Medical Systems, Inc. | 2013-10-04 | 18 | 0 |
| K083349 | BLOOD TRANSFUSION SET | Shan Dong Wei Gao Group Medical Polymer Products | 2009-04-10 | 148 | 0 |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND | Fenwal, Inc. | 2008-03-03 | 96 | 0 |
| K041496 | PENTATRASFU BLOOD TRANSFUSION SETS | Pentaferte S.P.A | 2005-06-30 | 391 | 0 |
| K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER | Blood Products Specialties, LLC | 2005-06-20 | 82 | 3 |
| K050115 | BLOOD HAND PUMP ADMINISTRATION SET | Cardinal Health, Alaris Products | 2005-04-01 | 73 | 0 |
| K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | 2002-11-07 | 56 | 0 |
| K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | 2000-08-15 | 168 | 0 |
| K993120 | MODIFIED BLOOD RECIPIENT SET | Baxter Healthcare Corp | 1999-11-17 | 58 | 10 |
| K972843 | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | 1997-12-16 | 137 | 0 |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Puritas Health Care, Inc. | 1994-04-21 | 105 | 0 |
| K940055 | MULTISET | Puritas Health Care, Inc. | 1994-04-15 | 100 | 0 |
| K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | 1992-12-24 | 265 | 0 |
| K920788 | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | 1992-06-04 | 105 | 0 |
| K880174 | JMS TRANSFUSION SET | Jms Co., Ltd. | 1988-02-16 | 32 | 0 |
| K871908 | IV ADMINISTRATION SET | Travenol Laboratories, S.A. | 1987-07-27 | 73 | 0 |
| K864441 | CHURCHILL BLOOD ADMINISTRATION SET | Churchill Corp. | 1987-01-20 | 69 | 0 |
| K861523 | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) | Jufrey Multimed Corp. | 1986-05-27 | 34 | 0 |
| K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I | Medelec Intl. Corp. | 1986-01-09 | 56 | 0 |
| K852167 | ISOVOL-EXCHANGE TRAY | Rocky Mountain Medical Corp. | 1985-11-18 | 182 | 0 |
| K853386 | MULTISET 40 | Migada, Ltd. | 1985-08-22 | 10 | 0 |
| K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | Vygon Corp. | 1985-05-03 | 18 | 0 |
| K841561 | HESUNG'S BLOOD DONOR SETS | Amkor Trading Co. | 1984-08-30 | 48 | 0 |
| K841187 | BLOOD COLLECTION SET, STERILE, DISPOS. | Marbex, Inc. | 1984-06-22 | 94 | 0 |
| K840411 | BLOOD & PLASMA ADMIN. DEV-STERILE | Loversan | 1984-03-19 | 48 | 0 |
| K833294 | ALPHA Y-RECIPIENT SET | Alpha Therapeutic Corp. | 1983-12-27 | 95 | 0 |
| K822409 | BOSTON BLOOD TRANSFUSION SETS | The Boston Medical Group | 1982-09-30 | 51 | 0 |
| K822410 | BOSTON BLOOD DONOR SETS | The Boston Medical Group | 1982-09-30 | 51 | 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