510(k) · Cleared
ClearedCediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cedic S.R.L. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Apr 25, 2019 as substantially equivalent to K141753 (Degania Silicone, Ltd., 2014) and 1 other predicate after a 294-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Apr 25, 2019
- Review
- 294 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913407 (1992). 7 ancestors in all, the oldest K831868 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK913407 Nasojejunal Feeding Tube W/Gastric DrainageSandoz Nutrition · 1992
- 2 generations backK961664 Compat Nasojejunal Feeding TubeSandoz Nutrition · 1996
- 1 generation backK141753 Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014
- This deviceK181787 Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913407 | Nasojejunal Feeding Tube W/Gastric Drainage | Sandoz Nutrition | 1992 | — |
| −2 | K961664 | Compat Nasojejunal Feeding Tube | Sandoz Nutrition | 1996 | — |
| −1 | K141753 | Aquarius Nasal Feeding Tube | Degania Silicone, Ltd. | 2014 | — |
| 0 (this device) | K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K141753 | Aquarius Nasal Feeding TubeSummary page 4…ntestinal Tube and Accessories (21 CFR 876.5980) Product Code: PIF Class: II Predicate Device(s) 1) Degania Aquarius Nasal Feeding Tubes (K141753) 2) Corpak MedSystems Neonatal Nasogastric Feeding Tube (K831328) Device Description The Cediflo and Cediflo Junior Enteral Feed… | 2014 |
| * | K831328 | Neonatal Nasogastric Feeding Tube-Summary page 4…PIF Class: II Predicate Device(s) 1) Degania Aquarius Nasal Feeding Tubes (K141753) 2) Corpak MedSystems Neonatal Nasogastric Feeding Tube (K831328) Device Description The Cediflo and Cediflo Junior Enteral Feeding Tubes are sterile, single use devices intended for use in acu… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.Maximum duration of use: 42 days. The Cediflo Junior Enteral Feeding Tubes…
Read the full statement (115 words)
The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.Maximum duration of use: 42 days.
The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181787: Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181787
Report an extraction error
Are you the manufacturer?
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