510(k) · Cleared
ClearedU Deliver Bolink ENFit Enteral Feeding Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U Deliver Medical, LLC · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on May 31, 2019 as substantially equivalent to K170555 (U Deliver Medical, LLC, 2017) after a 108-day review. Its family tree reaches back 2 generations to 2014. 2 later devices descend from it.
- Decided
- May 31, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132424 (2014). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK132424 MetrixcareThe Metrix Company · 2014
- 1 generation backK170555 U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC · 2017
- This deviceK190310 U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK242917 Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A. · 2025
- Descendant · cites it directly · 0 of its ownK223683 EnteraLoc FlowVonco Products · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132424 | Metrixcare | The Metrix Company | 2014 | — |
| −1 | K170555 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2017 | — |
| 0 (this device) | K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2019 | — |
| +1 | K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | 2025 | — |
| +1 | K223683 | EnteraLoc Flow | Vonco Products | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K170555 | U Deliver Bolink ENFit Enteral Feeding SetsSummary page 5…link Large Cap Gravity Feeding Set with ENFit Connector is designed with identical major dimensions to the predicate device, U Deliver Bolink ENFit Enteral Feeding Sets (K170555). Manufacture The U Deliver Bolink ENFit Enteral Feeding Sets are assembled from components manufactured by subcontractors/supp… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K242917 (HMC Premedical S.p.A., 2025) has gone furthest, with 0 descendants of its own.
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 U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190310: U Deliver Bolink ENFit Enteral Feeding Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190310
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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