Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Bio-Medicus, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
322 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | Medtronic Bio-Medicus, Inc. | 1998-04-27 | 242 | 0 |
| K973011 | BPX80 BIO-PUMP (BPX80) | Medtronic Bio-Medicus, Inc. | 1998-02-25 | 196 | 0 |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Medtronic Bio-Medicus, Inc. | 1996-01-16 | 110 | 0 |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | Medtronic Bio-Medicus, Inc. | 1995-02-17 | 303 | 0 |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONT | Medtronic Bio-Medicus, Inc. | 1994-12-23 | 366 | 0 |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | Medtronic Bio-Medicus, Inc. | 1994-07-20 | 91 | 1 |
| K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) | Medtronic Bio-Medicus, Inc. | 1993-07-08 | 322 | 0 |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | Medtronic Bio-Medicus, Inc. | 1993-06-02 | 163 | 0 |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | Medtronic Bio-Medicus, Inc. | 1993-05-07 | 260 | 0 |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | Medtronic Bio-Medicus, Inc. | 1993-05-06 | 259 | 0 |
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | Medtronic Bio-Medicus, Inc. | 1993-03-26 | 193 | 1 |
| K924643 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | Medtronic Bio-Medicus, Inc. | 1992-12-08 | 85 | 0 |
| K914754 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D | Medtronic Bio-Medicus, Inc. | 1992-05-20 | 211 | 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