Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medamicus, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
213 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040150 | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | Medamicus, Inc. | 2004-02-18 | 26 | 0 |
| K030905 | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | Medamicus, Inc. | 2003-04-09 | 16 | 0 |
| K022689 | MODIFICATION TO MEDAMICUS AXIA RSN | Medamicus, Inc. | 2002-08-23 | 10 | 0 |
| K021004 | VALVED PEELABLE INTRODUCER | Medamicus, Inc. | 2002-06-06 | 70 | 0 |
| K020563 | MEDAMICUS AXIA RSN | Medamicus, Inc. | 2002-05-21 | 90 | 0 |
| K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550 | Medamicus, Inc. | 2002-01-24 | 128 | 0 |
| K011085 | GUIDEWIRE INTRODUCER SAFETY NEEDLE | Medamicus, Inc. | 2001-07-09 | 90 | 0 |
| K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX | Medamicus, Inc. | 2000-04-13 | 30 | 0 |
| K994097 | MEDAMICUS EPIDURAL INTRODUCER | Medamicus, Inc. | 2000-03-01 | 89 | 0 |
| K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIF | Medamicus, Inc. | 1999-06-28 | 116 | 1 |
| K965167 | PERCUTANEOUS VENOUS INTRODUCER 10264 | Medamicus, Inc. | 1997-07-25 | 213 | 0 |
| K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | Medamicus, Inc. | 1997-06-03 | 36 | 0 |
| K953734 | LUMAX(MODIFICATION) | Medamicus, Inc. | 1996-01-18 | 185 | 0 |
| K954093 | LUMAX (MODIFICATION) | Medamicus, Inc. | 1996-01-11 | 155 | 0 |
| K951313 | MEDAMICUS PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1995-06-27 | 96 | 0 |
| K944107 | VIP PLUS PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1994-09-14 | 22 | 0 |
| K932323 | PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1993-11-09 | 182 | 0 |
| K920580 | TRANSDUCER, PRESSURE, CATHETER TIP | Medamicus, Inc. | 1993-01-07 | 332 | 0 |
| K924491 | INTRODUCER, PERCUTANEOUS -- MODIFICATION | Medamicus, Inc. | 1992-11-18 | 90 | 0 |
| K893658 | PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1989-08-03 | 80 | 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