Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lobob Laboratories, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014162 | MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND | Lobob Laboratories, Inc. | 2002-01-15 | 27 | 0 |
| K001964 | OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION | Lobob Laboratories, Inc. | 2000-07-18 | 21 | 0 |
| K001428 | OPTIMUM WETTING AND REWETTING DROP | Lobob Laboratories, Inc. | 2000-05-26 | 21 | 0 |
| K990044 | LOBOB UNIVERSAL CONTACT LENS CLEANER | Lobob Laboratories, Inc. | 1999-02-11 | 36 | 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