Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Blood Systems, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
276 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 | Medtronic Blood Systems, Inc. | 1995-07-14 | 280 | 0 |
| K944966 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 | Medtronic Blood Systems, Inc. | 1995-07-14 | 276 | 0 |
| K893207 | CLOSED CHEST SUPPORT CIRCUIT | Medtronic Blood Systems, Inc. | 1989-12-12 | 230 | 0 |
| K893678 | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H | Medtronic Blood Systems, Inc. | 1989-11-27 | 195 | 0 |
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE | Medtronic Blood Systems, Inc. | 1989-05-31 | 70 | 9 |
| K891230 | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. | Medtronic Blood Systems, Inc. | 1989-05-19 | 73 | 0 |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | 1989-02-22 | 69 | 0 |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | 1988-12-21 | 64 | 0 |
| K884244 | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-12-05 | 55 | 0 |
| K883439 | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM | Medtronic Blood Systems, Inc. | 1988-10-13 | 59 | 0 |
| K883086 | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-09-16 | 57 | 0 |
| K882137 | EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 | Medtronic Blood Systems, Inc. | 1988-08-12 | 84 | 0 |
| K882136 | INTERSEPT* OXYGEN GAS LINE FILTER | Medtronic Blood Systems, Inc. | 1988-08-11 | 83 | 0 |
| K882479 | 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP | Medtronic Blood Systems, Inc. | 1988-07-18 | 32 | 0 |
| K880671 | MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER | Medtronic Blood Systems, Inc. | 1988-05-06 | 78 | 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