Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cedic S.R.L. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
294 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feedi | Cedic S.R.L. | 2019-04-25 | 294 | 0 |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.R.L. | 2019-04-09 | 55 | 0 |
| K162254 | Cedic Enteral ENFit Transition Connectors | Cedic S.R.L. | 2017-05-04 | 267 | 0 |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medic | Cedic S.R.L. | 2015-04-02 | 90 | 0 |
| K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC E | Cedic S.R.L. | 2014-10-17 | 225 | 0 |
| K072652 | ENTERAL FEEDING SPIKE ADAPTER | Cedic S.R.L. | 2008-01-18 | 120 | 0 |
| K042129 | F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAV | Cedic S.R.L. | 2005-01-27 | 174 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda