Paco Pharmaceutical Services, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Paco Pharmaceutical Services, Inc.” (first 1977, latest 1987), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | 3 | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Paco Pharmaceutical Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | HPX | 1987-01-20 | 20 |
| K863974 | CHARTER LABORATORIES INC. LENS LUBRICANT | HPX | 1986-11-10 | 27 |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | HPX | 1986-09-25 | 51 |
| K843797 | STERILE SALINE SOLUTION | BSY | 1985-01-18 | 113 |
| K843796 | STERILE WATER | — | 1984-12-10 | 74 |
| K761093 | BANDAGE | NAD | 1977-01-06 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Paco Pharmaceutical Services, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Paco Research Corp. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paco Pharmaceutical Services, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Paco Pharmaceutical Services, Inc.” (first 1977, latest 1987), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Paco Pharmaceutical Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paco Pharmaceutical Services, Inc. is 48 days.
Which FDA product codes appear under Paco Pharmaceutical Services, Inc.?
The most frequent FDA product codes under this applicant name are HPX (Lens, Contact (Polymethylmethacrylate), 3); BSY (Catheters, Suction, Tracheobronchial, 1); NAD (Dressing, Wound, Occlusive, 1).
Next steps
- See all 6 Paco Pharmaceutical Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPX, Paco Pharmaceutical Services, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.