510(k) · Cleared
ClearedENFit to ENFit Extension Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesco Medical · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Nov 2, 2023 as substantially equivalent to K143018 (Covidien, 2015) after a 269-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Nov 2, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801558 (1980). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 2 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 1 generation backK143018 Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore…Covidien · 2015
- This deviceK230326 ENFit to ENFit Extension SetsVesco Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −2 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −1 | K143018 | Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors | Covidien | 2015 | — |
| 0 (this device) | K230326 | ENFit to ENFit Extension Sets | Vesco Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 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? (1)
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 |
|---|---|---|---|
| * | K143018 | Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore ConnectorsSummary page 4…ly Marketed Predicate Device Product name: Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors 510(k) Number: K143018 Manufacturer: Covidien (Cardinal Health) Product Code: PIF Device Class: Class II Vesco Medica… | 2015 |
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 43 years and passes through 4 companies; a new generation was cleared every 17.1 years on median.
- None of the 6 ancestors has a recall.
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. 2023, 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 ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications.
The device is single use for patients who require enteral feeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230326: ENFit to ENFit Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230326
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