Ellis Pharmaceutical Consulting, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ellis Pharmaceutical Consulting, Inc.” (first 1983, latest 1991), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 1 | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| KQA | Device, Beam Limiting, X-Ray, Therapeutic | 1 | 1 |
| LKB | Pad, Alcohol, Device Disinfectant | 1 | 1 |
Review panels
- General Hospital (3)
- Radiology (2)
Most recent Ellis Pharmaceutical Consulting, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910936 | EMPTY I.V. CONTAINER | KPE | 1991-07-16 | 132 |
| K884233 | QUADROJECT(TM) | FMF | 1989-01-30 | 115 |
| K852235 | STERETS INJECTION SWAB | LKB | 1985-06-07 | 16 |
| K844180 | THE MCP-70-SE SYSTEM | KQA | 1985-02-01 | 98 |
| K832789 | AFTER LOADING BUCHLER | JAQ | 1983-09-29 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Ellis Pharmaceutical Consulting, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ellis Pharmaceutical Consulting, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Ellis Pharmaceutical Consulting, Inc.” (first 1983, latest 1991), across 5 product codes in 2 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 Ellis Pharmaceutical Consulting, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ellis Pharmaceutical Consulting, Inc. is 98 days.
Which FDA product codes appear under Ellis Pharmaceutical Consulting, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 1); JAQ (System, Applicator, Radionuclide, Remote-Controlled, 1); KPE (Container, I.V., 1).
Next steps
- See all 5 Ellis Pharmaceutical Consulting, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Ellis Pharmaceutical Consulting, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.