Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vision Quest Industries, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
259 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | 2015-03-23 | 222 | 0 |
| K090532 | T.E.A.R. TECH3 | Vision Quest Industries, Inc. | 2009-11-13 | 259 | 0 |
| K072799 | TARGET STERILE ELECTRODE | Vision Quest Industries, Inc. | 2008-04-24 | 206 | 0 |
| K041092 | FAST START TENS, MODEL FS 3001 | Vision Quest Industries, Inc. | 2004-07-01 | 66 | 0 |
| K030507 | T.E.A.R. TECH3 MODEL #44TT03 | Vision Quest Industries, Inc. | 2003-05-20 | 90 | 0 |
| K982388 | SURGI STIM | Vision Quest Industries, Inc. | 1998-09-14 | 67 | 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