Delaware Prosthetics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Delaware Prosthetics, Inc.” (first 1983, latest 1983), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 157 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 |
|---|---|---|---|
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 3 | 3 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Delaware Prosthetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | GBI | 1983-12-19 | 167 |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | GBI | 1983-12-09 | 157 |
| K832152 | PDM SILOXANE PROSTHETIC EAR | GBI | 1983-12-09 | 157 |
| K832149 | PDM SILOXANE PROSTHETIC OBTURATOR | — | 1983-11-28 | 146 |
| K832148 | PDM SILOXANE PROSTHETIC CHIN IMPLANT | FWP | 1983-11-28 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Delaware Prosthetics, 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.
- Delaware Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Delaware Prosthetics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Delaware Prosthetics, Inc.” (first 1983, latest 1983), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Delaware Prosthetics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Delaware Prosthetics, Inc. is 157 days.
Which FDA product codes appear under Delaware Prosthetics, Inc.?
The most frequent FDA product codes under this applicant name are GBI (Material, External Aesthetic Restoration, Used With Adhesive, 3); FWP (Prosthesis, Chin, Internal, 1).
Next steps
- See all 5 Delaware Prosthetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GBI, Delaware Prosthetics, 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.