510(k) · Cleared
ClearedCedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cedic S.R.L. · PIO Enteral Specific Transition Connectors
Cleared on Oct 17, 2014 as substantially equivalent to K080340 (Novartis Nutrition Corp., 2008) and 3 other predicates after a 225-day review. Its family tree reaches back 2 generations to 1994. 8 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 225 days
- Class
- Class II
- Product code
- PIO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K940556 (1994). 6 ancestors in all. 8 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK940556 Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 1994 · Recalled
- 1 generation backK080340 Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing…Novartis Nutrition Corp. · 2008
- This deviceK140581 Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral…Cedic S.R.L. · 2014
- Descendant · cites it directly · 1 of its ownK150034 AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK231299 Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree…Cair Lgl · 2024
- Descendant · cites it directly · 0 of its ownK233190 ENFit AdaptorJiangsu Caina Medical Co.,Ltd · 2024
- Descendant · 2 generations on · 0 of its ownK162254 Cedic Enteral ENFit Transition ConnectorsCedic S.R.L. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · cites it directly1descendant
- K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd. · 2026 · cites it directly0descendants
- K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl · 2024 · cites it directly0descendants
- K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd · 2024 · cites it directly0descendants
- K162254Cedic Enteral ENFit Transition ConnectorsCedic S.R.L. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940556 | Sandoz Nutrition Compat (R) Enteral Feeding Pump | Sandoz Nutrition | 1994 | 2 |
| −1 | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and… | Novartis Nutrition Corp. | 2008 | — |
| 0 (this device) | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit… | Cedic S.R.L. | 2014 | — |
| +1 | K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | 2015 | 1 |
| +1 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral… | CMT Health PTE., Ltd. | 2026 | — |
| +1 | K231299 | Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector | Cair Lgl | 2024 | — |
| +1 | K233190 | ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd | 2024 | — |
| +2 | K162254 | Cedic Enteral ENFit Transition Connectors | Cedic S.R.L. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PIO device
- #1 K231299 Nutricair enteral ENFit adapter: ENFit male –…score 7.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer…Summary page 9…right Piercing Spike and 1000ml water bag 510(k) Sponsor: ................................... Novartis Nutrition Corp. 510(k) Number: ................................... K080340 Clearance Date: .................................. 5 March 2008 FDA Product Code: ............................. KNT Classificatio… | 2008 |
| * | K083786 | Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LBSummary page 9…......... Models 20-1006AIV-LB and 20-1030AIV-LB 510(k) Sponsor: ................................... Corpak Medsystems 510(k) Number: ................................... K083786 Clearance Date: .................................. 20 February 2009 FDA Product Code: ............................. FPD Classific… | 2009 |
| * | K083210 | Corflo Anti IV Enteral Feeding TubeSummary page 9…............ Corflo Anti IV Enteral Feeding Tube 510(k) Sponsor: ................................... Corpak Medsystems 510(k) Number: ................................... K083210 Clearance Date: .................................. 29 December 2008 FDA Product Code: ............................. FPD Classific… | 2008 |
| * | K072652 | Enteral Feeding Spike AdapterSummary page 8…43076356-ZT (2%). These materials and methods of manufacture have been used previously for the Cedic Enteral Feeding Spike Adapter, cleared by FDA under 510(k) reference K072652. Performance Data: In relation to performance data for such ENFit Transition Connectors, according to the FDA publication ‘Draf… | 2008 |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150034 | AMT Enteral Transition Adapters | 2015 | 1 |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe… | 2026 | 0 |
| K231299 | Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector | 2024 | 0 |
| K233190 | ENFit Adaptor | 2024 | 0 |
| K151237 | Nutrisafe 2- ENFit Adaptor | 2016 | 0 |
| K151628 | Medline ENFit Connectors | 2015 | 0 |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K150034 (Applied Medical Technology, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080340.
How does its category compare?
All PIO devicesPIO Enteral Specific Transition Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PIO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PIO
90in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIO
9in 2025
MAUDE reports naming product code PIO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 90 | 0 | 119 |
| 2016 | 1 | — | 0 | 215 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 1 | 6 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cedic Enteral Distal End ENFit Transition Connector is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.
The Cedic Enteral Funnel ENFit Transition Connector is intended for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140581
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026