Cedic S.R.L.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cedic S.R.L.” (first 2005, latest 2019), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 174 days. Since 2017 the median was 267 days, against 204 days for all cleared 510(k)s in the same product codes. 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 | 1 | 225 |
| 2015 | 1 | 90 |
| 2016 | 0 | — |
| 2017 | 1 | 267 |
| 2018 | 0 | — |
| 2019 | 2 | 174 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cedic S.R.L. took a median 267 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PIO | Enteral Specific Transition Connectors | 3 | 3 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Cedic S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | PIF | 2019-04-25 | 294 |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | PIF | 2019-04-09 | 55 |
| K162254 | Cedic Enteral ENFit Transition Connectors | PIO | 2017-05-04 | 267 |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | PIO | 2015-04-02 | 90 |
| K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT | PIO | 2014-10-17 | 225 |
| K072652 | ENTERAL FEEDING SPIKE ADAPTER | KNT | 2008-01-18 | 120 |
| K042129 | F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK | FPA | 2005-01-27 | 174 |
Recalls
openFDA lists no recalls under a recalling firm named Cedic 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cedic S.R.L.?
FDA lists 7 510(k) clearances under the applicant name “Cedic S.R.L.” (first 2005, latest 2019), across 4 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 Cedic S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cedic S.R.L. is 174 days. Since 2017: 267 days, versus 204 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cedic S.R.L.?
The most frequent FDA product codes under this applicant name are PIO (Enteral Specific Transition Connectors, 3); PIF (Gastrointestinal Tubes With Enteral Specific Connectors, 2); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 7 Cedic S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code PIO, Cedic 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, 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.