Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med Institute, Inc. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
557 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990034 | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | 2000-04-17 | 467 | 0 |
| K982507 | MINI POLYURETHANE CATHETER | Med Institute, Inc. | 1998-09-16 | 58 | 0 |
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | Med Institute, Inc. | 1998-05-26 | 64 | 0 |
| K964001 | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM | Med Institute, Inc. | 1998-04-17 | 557 | 0 |
| K971140 | VITAL-PORT INFUSION PAL | Med Institute, Inc. | 1997-11-17 | 234 | 0 |
| K970442 | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1997-04-30 | 84 | 0 |
| K945586 | FLEXIBLE DILATING SHEATH | Med Institute, Inc. | 1997-04-04 | 872 | 0 |
| K960698 | NON-CORING NEEDLE | Med Institute, Inc. | 1996-04-15 | 55 | 0 |
| K941228 | ENDOLUMINAL ACCESS TUBE | Med Institute, Inc. | 1995-09-27 | 561 | 0 |
| K951077 | VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1995-07-31 | 144 | 0 |
| K951076 | VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1995-06-13 | 96 | 0 |
| K932411 | VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA | Med Institute, Inc. | 1994-09-19 | 489 | 0 |
| K934520 | VITAL-PORT VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1994-09-06 | 351 | 0 |
| K931586 | VITAL-PORT MINI VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1993-09-27 | 180 | 0 |
| K924748 | VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P | Med Institute, Inc. | 1993-07-28 | 309 | 2 |
| K922896 | VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL | Med Institute, Inc. | 1993-03-20 | 277 | 0 |
| K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | Med Institute, Inc. | 1992-07-30 | 72 | 0 |
| K921201 | VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. | Med Institute, Inc. | 1992-07-21 | 131 | 0 |
| K914555 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) | Med Institute, Inc. | 1992-01-03 | 88 | 0 |
| K913350 | VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1991-08-09 | 14 | 0 |
| K912465 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121 | Med Institute, Inc. | 1991-07-30 | 56 | 0 |
| K912424 | VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110 | Med Institute, Inc. | 1991-07-30 | 60 | 0 |
| K912423 | VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112 | Med Institute, Inc. | 1991-07-30 | 60 | 0 |
| K911449 | VITAL-PORT VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1991-06-24 | 96 | 0 |
| K910005 | VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1991-03-13 | 70 | 0 |
| K904077 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1990-10-17 | 42 | 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