Oldelft Corp. of America: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Oldelft Corp. of America” (first 1989, latest 1998), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 148 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IZG | System, X-Ray, Photofluorographic | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| KQA | Device, Beam Limiting, X-Ray, Therapeutic | 1 | 1 |
Review panels
- Radiology (9)
Most recent Oldelft Corp. of America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980296 | OLDELFT DIGIDELCA | KPR | 1998-04-17 | 80 |
| K973219 | AMBER DU | KPR | 1997-10-08 | 42 |
| K946128 | SIMULIX-HP | KPQ | 1995-05-12 | 148 |
| K950037 | N 800 HF | IZO | 1995-02-15 | 42 |
| K932848 | SIMULIX-MC CT EXTENSION | JAK | 1994-03-22 | 285 |
| K923584 | THERAPAX DXT 300 SERIES 3 | JAD | 1993-01-15 | 179 |
| K914784 | PAPILLION PROCTOSCOPE | KQA | 1992-06-05 | 226 |
| K912466 | OLDELFT SIMULIX-MC | KPQ | 1991-06-28 | 24 |
| K892659 | ELECTRODELCA | IZG | 1989-11-21 | 222 |
Recalls
openFDA lists no recalls under a recalling firm named Oldelft Corp. of America.
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 Oldelft Corp. of America?
FDA lists 9 510(k) clearances under the applicant name “Oldelft Corp. of America” (first 1989, latest 1998), across 7 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 Oldelft Corp. of America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oldelft Corp. of America is 148 days.
Which FDA product codes appear under Oldelft Corp. of America?
The most frequent FDA product codes under this applicant name are KPQ (System, Simulation, Radiation Therapy, 2); KPR (System, X-Ray, Stationary, 2); IZG (System, X-Ray, Photofluorographic, 1).
Next steps
- See all 9 Oldelft Corp. of America clearances with predicates and recalls
- Run predicate analysis for product code KPQ, Oldelft Corp. of America'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.