Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paco Pharmaceutical Services, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
113 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | Paco Pharmaceutical Services, Inc. | 1987-01-20 | 20 | 0 |
| K863974 | CHARTER LABORATORIES INC. LENS LUBRICANT | Paco Pharmaceutical Services, Inc. | 1986-11-10 | 27 | 0 |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | Paco Pharmaceutical Services, Inc. | 1986-09-25 | 51 | 0 |
| K843797 | STERILE SALINE SOLUTION | Paco Pharmaceutical Services, Inc. | 1985-01-18 | 113 | 0 |
| K843796 | STERILE WATER | Paco Pharmaceutical Services, Inc. | 1984-12-10 | 74 | 0 |
| K761093 | BANDAGE | Paco Pharmaceutical Services, Inc. | 1977-01-06 | 45 | 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