Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HOO — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
146 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941723 | WELCH ALLYN GLAUCOMA DETECTOR | Welch Allyn, Inc. | 1994-06-06 | 60 | 0 |
| K930448 | MARCO PROJECTION PERIMETER | Marco Ophthalmic, Inc. | 1993-06-21 | 146 | 0 |
| K873912 | RICHMOND VISUAL FIELD SCREENER | Richmond Products, Inc. | 1987-11-02 | 38 | 0 |
| K864467 | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN | Keeler Instruments, Inc. | 1986-12-15 | 33 | 0 |
| K860115 | DIGILAB CAMBRIDGE PERIMETER | Bio-Rad | 1986-02-27 | 45 | 0 |
| K832800 | AUTOMATIC TANGENT SCREEN 50 | CooperVision, Inc. | 1983-09-29 | 42 | 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