Pfizer Hospital Products Group, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Pfizer Hospital Products Group, Inc.” (first 1991, latest 1994), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Review panels
Most recent Pfizer Hospital Products Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930156 | MEGA PLUS SUPER LAG SCREW | KTT | 1994-02-22 | 405 |
| K915512 | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS | JWH | 1992-08-18 | 253 |
| K920831 | PCA TOTAL HIP SYSTEM (CEMENTLESS USE) | LPH | 1992-06-10 | 111 |
| K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC | JWH | 1992-03-18 | 72 |
| K915184 | HOWMEDICA ALUMINA FEMORAL HEAD | LZO | 1992-01-31 | 74 |
| K911656 | PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST | CAC | 1991-08-13 | 123 |
| K911292 | SCHNEIDER WALLSTENT(R) | FGE | 1991-05-01 | 37 |
| K905482 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE | GAM | 1991-03-14 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Pfizer Hospital Products Group, 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.
- Pfizer Laser Systems (32 510(k)s)
- Pfizer, Inc. (30 510(k)s)
- Pfizer Medical Systems, Inc. (12 510(k)s)
- Pfizer Pharmaceuticals (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pfizer Hospital Products Group, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Pfizer Hospital Products Group, Inc.” (first 1991, latest 1994), across 7 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 Hospital Products Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pfizer Hospital Products Group, Inc. is 104 days.
Which FDA product codes appear under Pfizer Hospital Products Group, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2); CAC (Apparatus, Autotransfusion, 1); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 8 Pfizer Hospital Products Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Pfizer Hospital Products Group, 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.