Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Vascular, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
208 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002233 | BVI SLING | Bio-Vascular, Inc. | 2000-10-13 | 81 | 0 |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (N | Bio-Vascular, Inc. | 2000-02-22 | 208 | 0 |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Bio-Vascular, Inc. | 1998-11-12 | 30 | 3 |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | 1998-11-06 | 24 | 0 |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PER | Bio-Vascular, Inc. | 1998-10-09 | 29 | 2 |
| K981624 | FLO-THRU | Bio-Vascular, Inc. | 1998-08-04 | 89 | 3 |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | Bio-Vascular, Inc. | 1998-07-30 | 30 | 1 |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Bio-Vascular, Inc. | 1998-04-10 | 336 | 0 |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | Bio-Vascular, Inc. | 1997-12-24 | 86 | 0 |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMP | Bio-Vascular, Inc. | 1997-12-16 | 88 | 0 |
| K971048 | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT | Bio-Vascular, Inc. | 1997-05-09 | 49 | 0 |
| K963697 | ADVANCED DIAGNOSTIC VIEWER (ADV) | Bio-Vascular, Inc. | 1996-11-27 | 72 | 0 |
| K961810 | SUPPLE PERI-GUARD PERICARDIUM | Bio-Vascular, Inc. | 1996-06-13 | 34 | 0 |
| K961811 | PERI-GUARD PERICARDIUM | Bio-Vascular, Inc. | 1996-06-13 | 34 | 0 |
| K950956 | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE | Bio-Vascular, Inc. | 1995-06-02 | 92 | 0 |
| K942812 | FLO-RESTER DISPOSABLE VESSEL OCCLUDER | Bio-Vascular, Inc. | 1994-08-01 | 48 | 1 |
| K942583 | PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT | Bio-Vascular, Inc. | 1994-07-08 | 37 | 0 |
| K942010 | VASCU-GUARD | Bio-Vascular, Inc. | 1994-07-07 | 73 | 0 |
| K940205 | PERI-STRIPS | Bio-Vascular, Inc. | 1994-05-02 | 108 | 0 |
| K923657 | SUPPLE PERI-GUARD | Bio-Vascular, Inc. | 1992-12-21 | 208 | 0 |
| K921895 | TISSUE PATCH, TISSUE GRAFT | Bio-Vascular, Inc. | 1992-11-04 | 196 | 0 |
| K910682 | ROBICSEK PROBE/RETRACTOR | Bio-Vascular, Inc. | 1991-05-08 | 78 | 0 |
| K905159 | FLO-RESTER(R) VESSEL SIZER | Bio-Vascular, Inc. | 1991-02-07 | 83 | 0 |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | 1990-01-19 | 80 | 0 |
| K883696 | FLO-RESTER | Bio-Vascular, Inc. | 1988-11-30 | 92 | 1 |
| K860523 | CARDIO-COOL | Bio-Vascular, Inc. | 1986-04-29 | 76 | 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