Pfizer, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Pfizer, Inc.” (first 1977, latest 2018), plus 9 PMA decisions, across 25 product codes in 13 review panels. Median 510(k) review time under this name: 72 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 | 1 | 142 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pfizer, Inc. took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTT | Susceptibility Test Powders, Antimicrobial | 7 | 0 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| EXB | Collector, Ostomy | 2 | 2 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| EFW | Toothbrush, Manual | 1 | 1 |
Plus 15 more product codes.
Review panels
- Microbiology (10)
- Orthopedic (9)
- Ophthalmic (3)
- Radiology (3)
- General and Plastic Surgery (3)
- Clinical Chemistry (2)
- Cardiovascular (2)
- Gastroenterology and Urology (2)
- Dental (1)
- Hematology (1)
- General Hospital (1)
- Neurology (1)
- Pathology (1)
Most recent Pfizer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181102 | ThermaCare Quick Therapy TENS | NUH | 2018-09-15 | 142 |
| K991620 | VISINE FOR CONTACTS | LPN | 1999-09-24 | 136 |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | EFW | 1989-06-14 | 70 |
| K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | FRO | 1989-06-05 | 60 |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | LXI | 1988-06-17 | 77 |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | EXB | 1986-02-24 | 91 |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | KWA | 1985-07-15 | 136 |
| K850443 | MEC ROD CONNECTOR | KTT | 1985-07-15 | 160 |
| K850413 | MEC HIP BOLT | KTT | 1985-07-15 | 161 |
| K850403 | MEC DISTAL FEMORAL BOLT | KTT | 1985-07-15 | 164 |
20 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N18286 | PMA | GELFOAM | 1983-07-08 |
| N50413 | PMA | GEOPEN SUSCEPTIBILITY POWDER | 1970-09-10 |
| N50009 | PMA | TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER | 1970-02-27 |
| N50042 | PMA | POTASSIUM PENICILLIN G DIAG SYS POWDER | 1970-02-27 |
| N50062 | PMA | OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER | 1969-11-24 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-10-02.
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.
Device clinical trials
An industry sponsor named Pfizer, Inc. is the lead sponsor of 23 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07542886: A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults (Recruiting, started 2026-04-22)
- NCT06140290: A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants (Completed, started 2023-12-20)
- NCT05745701: A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults (Completed, started 2023-02-22)
- NCT04893798: A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen (Completed, started 2021-09-16)
- NCT04823650: Monitoring Activity And Gait In Children (Completed, started 2021-08-23)
SEC filings
PFIZER INC (PFE): EDGAR filings, CIK 78003. An SEC registrant with the same name, matched by name only.
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 Medical Systems, Inc. (12 510(k)s)
- Pfizer Hospital Products Group, Inc. (8 510(k)s)
- Pfizer Pharmaceuticals (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pfizer, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Pfizer, Inc.” (first 1977, latest 2018), plus 9 PMA decisions, across 25 product codes in 13 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pfizer, Inc. is 72 days.
Which FDA product codes appear under Pfizer, Inc.?
The most frequent FDA product codes under this applicant name are JTT (Susceptibility Test Powders, Antimicrobial, 7); HRS (Plate, Fixation, Bone, 3); JAK (System, X-Ray, Tomography, Computed, 3).
Next steps
- See all 30 Pfizer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTT, Pfizer, 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.