510(k) · Cleared
ClearedVesco Medical Nasoenteric Feeding Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesco Medical, LLC · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Sep 26, 2017 as substantially equivalent to K112511 (Covidien Lp, Formerly Registered AS Kendall, 2012) and 1 other predicate after a 251-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Sep 26, 2017
- Review
- 251 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831868 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831868 | Dobbhoff Feeding Tube W/Hydromer Lub | Biosearch Medical Products, Inc. | 1983 | — |
| −1 | K112511 | Dobbhoff Dual Port Feeding Tube | Covidien Lp, Formerly Registered AS Kendall | 2012 | — |
| 0 (this device) | K170162 | Vesco Medical Nasoenteric Feeding Tubes | Vesco Medical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K112511 | Dobbhoff Dual Port Feeding TubeSummary page 4…5980) / PIF III. Legally Marketed Predicate Devices • Covidien Dobbhoff™ Dual Port Feeding Tubes were most recently cleared under notification K112511. • Ross Product Division Abbott Laboratories Flexiflo Enteral Feeding Tubes were most recently cleared under no… | 2012 |
| * | K992494 | Flexiflo Enteral Feeding TubeSummary page 4…otification K112511. • Ross Product Division Abbott Laboratories Flexiflo Enteral Feeding Tubes were most recently cleared under notification K992494. IV. Device Description The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices cons… | 1999 |
| † | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition… | 2014 |
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 34 years and passes through 3 companies; a new generation was cleared every 28.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K112511.
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. 2017, 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 Vesco Medical Nasoenteric Feeding Tubes (NE Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (<30 days).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170162: Vesco Medical Nasoenteric 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/K170162
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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