Dideco: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dideco” (first 1995, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 282 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Dideco 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K004001 | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR | DTZ | 2001-10-04 | 282 |
| K010478 | DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR | DTZ | 2001-09-27 | 219 |
| K001388 | DATA MASTER PERFUSION MONITORING SYSTEM | DRY | 2000-07-28 | 87 |
| K936220 | DIDECO VACUUM PUMP | CAC | 1995-01-27 | 395 |
| K940519 | DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM | CAC | 1995-01-19 | 349 |
Recalls
openFDA lists no recalls under a recalling firm named Dideco.
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.
- Dideco S.P.A. (22 510(k)s)
- Dideco S.R.L. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dideco?
FDA lists 5 510(k) clearances under the applicant name “Dideco” (first 1995, latest 2001), 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 Dideco?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dideco is 282 days.
Which FDA product codes appear under Dideco?
The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 2); DTZ (Oxygenator, Cardiopulmonary Bypass, 2); DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 1).
Next steps
- See all 5 Dideco clearances with predicates and recalls
- Run predicate analysis for product code CAC, Dideco'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.