Dideco S.R.L.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dideco S.R.L.” (first 1996, latest 2005), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 3 | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Dideco S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052717 | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER | DTM | 2005-10-20 | 21 |
| K051232 | D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER | DTM | 2005-05-20 | 7 |
| K050890 | ECC.O SYSTEM | KFM | 2005-05-05 | 27 |
| K050447 | PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | 2005-03-08 | 14 |
| K043323 | D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | DTZ | 2005-02-01 | 61 |
| K953835 | LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR | DTZ | 1996-03-15 | 212 |
Recalls
openFDA lists no recalls under a recalling firm named Dideco S.R.L..
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 (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dideco S.R.L.?
FDA lists 6 510(k) clearances under the applicant name “Dideco S.R.L.” (first 1996, latest 2005), 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 S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dideco S.R.L. is 24 days.
Which FDA product codes appear under Dideco S.R.L.?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 3); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 2); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 1).
Next steps
- See all 6 Dideco S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Dideco S.R.L.'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.