Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vista Medical Technologies, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
125 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021290 | VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION | Vista Medical Technologies, Inc. | 2002-06-28 | 66 | 0 |
| K020301 | MODIFICATION TO VISTA STEREOSCOPE SYSTEM | Vista Medical Technologies, Inc. | 2002-02-12 | 14 | 0 |
| K991303 | VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE | Vista Medical Technologies, Inc. | 1999-07-12 | 87 | 0 |
| K990635 | VISTA STEREOSCOPE SYSTEM | Vista Medical Technologies, Inc. | 1999-05-19 | 82 | 0 |
| K973436 | VISTA HEAD MOUNTED DISPLAY | Vista Medical Technologies, Inc. | 1997-12-09 | 90 | 0 |
| K971373 | VISTA SINGLE CHIP VIDEO CAMERA | Vista Medical Technologies, Inc. | 1997-05-20 | 36 | 1 |
| K970217 | VISTA ILLUMINATION SYSTEM | Vista Medical Technologies, Inc. | 1997-04-02 | 71 | 0 |
| K961800 | HEAD MOUNTED DISPLAY | Vista Medical Technologies, Inc. | 1996-09-11 | 125 | 0 |
| K953888 | TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIA | Vista Medical Technologies, Inc. | 1995-10-07 | 51 | 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