510(k) Report

FDA applicant

Cedic S.R.L.

Peschiera Borromeo, IT7 decisions2005–20190 recalls

FDA records 7 decisions for Cedic S.R.L. (Peschiera Borromeo, IT) from 2005 to 2019: 7 510(k) clearances. Most are in product codes PIO (Enteral Specific Transition Connectors) and PIF (Gastrointestinal Tubes With Enteral Specific…). Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Cedic S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2008: 12014: 12015: 12017: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cedic S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cedic S.R.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PIOEnteral Specific Transition Connectors3decisions
  • PIFGastrointestinal Tubes With Enteral Specific Connectors2decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication…Cedic S.R.L. · 20147cite it
  • K072652Enteral Feeding Spike AdapterCedic S.R.L. · 20082cite it

What has FDA decided for it lately?

  • K181787Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019
  • K190327ENConnect 40 mm Screw Cap to ENPlus AdapterCedic S.R.L. · 2019
  • K162254Cedic Enteral ENFit Transition ConnectorsCedic S.R.L. · 2017
  • K150010Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortCedic S.R.L. · 2015
  • K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication…Cedic S.R.L. · 2014
  • K072652Enteral Feeding Spike AdapterCedic S.R.L. · 2008
  • K042129F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer LockCedic S.R.L. · 2005

All 7 as Cedic S.R.L. →