Parke-Davis Co.: FDA filings under this applicant name
FDA lists 47 510(k) clearances under the applicant name “Parke-Davis Co.” (first 1976, latest 1986), across 25 product codes in 8 review panels. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 14 | 14 |
| BSO | Catheter, Conduction, Anesthetic | 3 | 3 |
| DYG | Catheter, Flow Directed | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 2 | 2 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Plus 15 more product codes.
Review panels
- General Hospital (22)
- Cardiovascular (10)
- Anesthesiology (3)
- Physical Medicine (3)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Parke-Davis Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | FOZ | 1986-12-04 | 212 |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | DYG | 1986-08-29 | 87 |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | FRC | 1986-06-18 | 177 |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | KRA | 1986-03-31 | 45 |
| K860290 | VIAPIC CENTRAL LINE CATHETER | FOZ | 1986-03-18 | 49 |
| K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK | FRC | 1985-11-01 | 165 |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | DXG | 1985-08-19 | 461 |
| K851327 | DESERET ARTERIAL CATHETER | FOZ | 1985-06-14 | 71 |
| K852078 | SPECTRUM(TENTATIVE) | FOZ | 1985-06-07 | 25 |
| K844840 | DESERET INTRODUCER SET | DYB | 1985-05-16 | 155 |
37 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Parke-Davis Co..
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 Parke-Davis Co.?
FDA lists 47 510(k) clearances under the applicant name “Parke-Davis Co.” (first 1976, latest 1986), across 25 product codes in 8 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 Parke-Davis Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Parke-Davis Co. is 51 days.
Which FDA product codes appear under Parke-Davis Co.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 14); BSO (Catheter, Conduction, Anesthetic, 3); DYG (Catheter, Flow Directed, 3).
Next steps
- See all 47 Parke-Davis Co. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Parke-Davis Co.'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.