Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HLP · 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) |
|---|---|---|---|---|---|
| K883471 | VKG 1000, VIDEO KERATOMETER | Technitex, Inc. | 1988-11-08 | 84 | 0 |
| K874250 | THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. | Richmond Products, Inc. | 1988-01-11 | 84 | 0 |
| K874251 | WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT | Richmond Products, Inc. | 1988-01-11 | 84 | 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