Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oculab, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
92 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884619 | PACH-PEN CALCULATOR | Oculab, Inc. | 1989-02-02 | 90 | 0 |
| K882750 | OCU-FILM TIP COVER | Oculab, Inc. | 1988-08-04 | 30 | 0 |
| K862016 | PACH-PEN SURGICAL DRAPE | Oculab, Inc. | 1986-06-04 | 7 | 0 |
| K860205 | BIO-PEN CALCULATOR | Oculab, Inc. | 1986-04-24 | 92 | 0 |
| K860061 | OCULAB BIOMETRICPEN | Oculab, Inc. | 1986-03-10 | 63 | 0 |
| K860062 | OCULAB PACHPEN | Oculab, Inc. | 1986-03-10 | 63 | 0 |
| K852774 | OCULAB TONOPEN | Oculab, Inc. | 1985-08-20 | 50 | 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