Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Visualization Technology, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
90 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003510 | INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 | Visualization Technology, Inc. | 2001-02-12 | 90 | 2 |
| K994270 | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 | Visualization Technology, Inc. | 2000-03-09 | 80 | 3 |
| K990919 | STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR, | Visualization Technology, Inc. | 1999-04-15 | 28 | 1 |
| K983529 | INSTATRAK 3000 | Visualization Technology, Inc. | 1998-12-31 | 84 | 6 |
| K982994 | SKULL BASE INSTATRAK SYSTEM | Visualization Technology, Inc. | 1998-11-16 | 81 | 1 |
| K981998 | PEDIATRIC INSTATRAK SYSTEM | Visualization Technology, Inc. | 1998-08-21 | 74 | 1 |
| K960330 | INSTATRAK | Visualization Technology, Inc. | 1996-04-08 | 75 | 9 |
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