Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovision, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
328 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151146 | N-Force Fixation System | Innovision, Inc. | 2015-07-24 | 86 | 0 |
| K132244 | N-FORCE FIXATION SYSTEM | Innovision, Inc. | 2014-03-06 | 231 | 0 |
| K102528 | N-FORCE FIXATION SYSTEM | Innovision, Inc. | 2011-07-28 | 328 | 0 |
| K011914 | HYDRO2, HS-75 | Innovision, Inc. | 2001-07-27 | 38 | 0 |
| K000485 | HYDRO2, HS-75 | Innovision, Inc. | 2000-05-12 | 88 | 0 |
| K944223 | ACCUCON | Innovision, Inc. | 1994-12-07 | 99 | 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