510(k) · Cleared
Recalled · Class II · 2026Medline ENFit Connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · PIO Enteral Specific Transition Connectors
Cleared on Jul 24, 2015 as substantially equivalent to K140581 (Cedic S.R.L., 2014) after a 37-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.
- Decided
- Jul 24, 2015
- Review
- 37 days
- Class
- Class II
- Product code
- PIO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940556 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK940556 Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 1994 · Recalled
- 2 generations backK080340 Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing…Novartis Nutrition Corp. · 2008
- 1 generation backK140581 Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral…Cedic S.R.L. · 2014
- This deviceK151628 Medline ENFit ConnectorsMedline Industries, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940556 | Sandoz Nutrition Compat (R) Enteral Feeding Pump | Sandoz Nutrition | 1994 | 2 |
| −2 | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and… | Novartis Nutrition Corp. | 2008 | — |
| −1 | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit… | Cedic S.R.L. | 2014 | — |
| 0 (this device) | K151628 | Medline ENFit Connectors | Medline Industries, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Summary page 6…L 60060 Medline ENFit G-Tube Connector PREDICATE DEVICE Cedic ENFit Transition Connectors for Enteral Applications (K140581) are identified herein as the predicate device of the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector.… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2026 | Class II | Z-1690-2026 | Process change control | Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 6 other devices also cite its predicate K140581.
How does its category compare?
All PIO devicesPIO Enteral Specific Transition Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Medline ENFit Transition Connector is intended for connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel.
The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151628: Medline ENFit Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151628
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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