Transamerica Delaval, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Transamerica Delaval, Inc.” (first 1984, latest 1986), across 2 product codes in 2 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 6 | 6 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Review panels
- Cardiovascular (6)
- General Hospital (1)
Most recent Transamerica Delaval, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853996 | DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE | DRS | 1986-05-07 | 219 |
| K851989 | DOME, DISPOSABLE, STERILE | DRS | 1985-08-19 | 104 |
| K851988 | ADMINISTRATION SET | DRS | 1985-08-16 | 101 |
| K851987 | FLUSH DEVICE, AUTOMATIC | DRS | 1985-08-16 | 101 |
| K851986 | STOPCOCKS | FMG | 1985-05-23 | 16 |
| K833171 | MONITORING KIT | DRS | 1984-09-06 | 356 |
| K833170 | FLUSH DEVICE | DRS | 1984-08-12 | 331 |
Recalls
openFDA lists no recalls under a recalling firm named Transamerica Delaval, 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.
- Transamerica Medical Systems (3 510(k)s)
- Transamerica Biomedical, Inc. (1 510(k)s)
- Transamerica Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Transamerica Delaval, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Transamerica Delaval, Inc.” (first 1984, latest 1986), across 2 product codes in 2 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 Transamerica Delaval, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transamerica Delaval, Inc. is 104 days.
Which FDA product codes appear under Transamerica Delaval, Inc.?
The most frequent FDA product codes under this applicant name are DRS (Transducer, Blood-Pressure, Extravascular, 6); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 7 Transamerica Delaval, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRS, Transamerica Delaval, 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.