Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HIW · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930575 | KAMPPETER ANOMALOSCOPE | Bova Intl. | 1994-02-25 | 386 | 0 |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Lkc Technologies, Inc. | 1991-10-23 | 48 | 0 |
| K860174 | GUNKEL CHROMAGRAPH COLOR VISION TESTER | Chromagraphics, Inc. | 1986-04-04 | 77 | 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