Pfizer Pharmaceuticals: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pfizer Pharmaceuticals” (first 1977, latest 1989), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GMY | Antisera, Fluorescent, All Types, Escherichia Coli | 1 | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 | 1 |
| JSC | Culture Media, General Nutrient Broth | 1 | 1 |
| JTN | Susceptibility Test Discs, Antimicrobial | 1 | 1 |
Review panels
Most recent Pfizer Pharmaceuticals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K885321 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | FRO | 1989-03-22 | 84 |
| K810427 | CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. | JTN | 1981-03-31 | 41 |
| K802408 | E-VAC BLOOD CULTURE SYSTEM | JSC | 1980-10-23 | 20 |
| K771605 | CREATINE KINASE ISOENZYME SUBSTRATE SET | JHX | 1977-09-15 | 24 |
| K770801 | MICROBIO. PROD. FLUORESCENT ANTIBODY | GMY | 1977-05-25 | 23 |
| K770425 | NEEDLES, STERILE, AIRWAY | FMI | 1977-04-15 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Pfizer Pharmaceuticals.
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.
- Pfizer Laser Systems (32 510(k)s)
- Pfizer, Inc. (30 510(k)s)
- Pfizer Medical Systems, Inc. (12 510(k)s)
- Pfizer Hospital Products Group, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pfizer Pharmaceuticals?
FDA lists 6 510(k) clearances under the applicant name “Pfizer Pharmaceuticals” (first 1977, latest 1989), across 6 product codes in 4 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 Pfizer Pharmaceuticals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pfizer Pharmaceuticals is 32 days.
Which FDA product codes appear under Pfizer Pharmaceuticals?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 1); FRO (Dressing, Wound, Drug, 1); GMY (Antisera, Fluorescent, All Types, Escherichia Coli, 1).
Next steps
- See all 6 Pfizer Pharmaceuticals clearances with predicates and recalls
- Run predicate analysis for product code FMI, Pfizer Pharmaceuticals'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.