Dideco S.P.A.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Dideco S.P.A.” (first 1997, latest 2004), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 | 10 | 10 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 | 2 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
Review panels
Most recent Dideco S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041061 | D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS | DTM | 2004-05-06 | 13 |
| K033323 | D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING | DTZ | 2004-01-13 | 90 |
| K033987 | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS | DTM | 2004-01-08 | 16 |
| K033714 | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING | DTN | 2003-12-11 | 15 |
| K032040 | IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR | KFM | 2003-07-09 | 8 |
| K031223 | SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR | DTZ | 2003-05-02 | 14 |
| K030154 | IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR | KFM | 2003-03-31 | 74 |
| K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT | KDI | 2002-11-04 | 164 |
| K022450 | INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY | DTZ | 2002-10-22 | 88 |
| K020647 | DIDECO ELECTA | CAC | 2002-09-05 | 189 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dideco S.P.A..
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.R.L. (6 510(k)s)
- Dideco (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dideco S.P.A.?
FDA lists 22 510(k) clearances under the applicant name “Dideco S.P.A.” (first 1997, latest 2004), across 8 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 Dideco S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dideco S.P.A. is 52 days.
Which FDA product codes appear under Dideco S.P.A.?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 10); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 3); CAC (Apparatus, Autotransfusion, 2).
Next steps
- See all 22 Dideco S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Dideco S.P.A.'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.