The DU Pont Co.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “The DU Pont Co.” (first 1988, latest 1995), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 2 |
| LMC | Camera, Multi Format, Radiological | 2 | 2 |
| CEL | Ammonium Molybdate And Ammonium Vanadate, Phospholipids | 1 | 1 |
| DLJ | Calibrators, Drug Specific | 1 | 1 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| KDL | Set, Perfusion, Kidney, Disposable | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent The DU Pont Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953477 | MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING | LMC | 1995-10-07 | 75 |
| K953475 | CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING | LMC | 1995-10-07 | 75 |
| K952891 | CRONEX LOW ABSORPTION CASSETTE | IXA | 1995-07-13 | 20 |
| K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD | LEH | 1995-03-10 | 142 |
| K943704 | LIPASE CALIBRATOR | JIT | 1994-09-14 | 44 |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | KDL | 1990-03-20 | 46 |
| K885259 | ACA THYRONINE UPTAKE (TU E) METHOD | KHQ | 1989-02-17 | 56 |
| K885258 | ACA THYROXINE (T4 E) METHOD | KLI | 1989-02-17 | 56 |
| K884700 | ANALYST THYROXINE (T4) ROTOR | KLI | 1989-01-27 | 79 |
| K884169 | DU PONT ANALYST THYROID ROTOR | CEL | 1989-01-24 | 112 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The DU Pont 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 The DU Pont Co.?
FDA lists 13 510(k) clearances under the applicant name “The DU Pont Co.” (first 1988, latest 1995), across 11 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 The DU Pont Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The DU Pont Co. is 56 days.
Which FDA product codes appear under The DU Pont Co.?
The most frequent FDA product codes under this applicant name are KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, 2); LMC (Camera, Multi Format, Radiological, 2); CEL (Ammonium Molybdate And Ammonium Vanadate, Phospholipids, 1).
Next steps
- See all 13 The DU Pont Co. clearances with predicates and recalls
- Run predicate analysis for product code KLI, The DU Pont 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.