510(k) · Cleared
ClearedMedline Quick Switch Valve with ENFit Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Dec 4, 2019 as substantially equivalent to K915171 (Icu Medical, Inc., 1992) after a 156-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 4, 2019
- Review
- 156 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915171 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915171 Lopez Valve TM IIIcu Medical, Inc. · 1992
- This deviceK191759 Medline Quick Switch Valve with ENFit ConnectorMedline Industries, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915171 | Lopez Valve TM II | Icu Medical, Inc. | 1992 | — |
| 0 (this device) | K191759 | Medline Quick Switch Valve with ENFit Connector | Medline Industries, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K915171 | Lopez Valve TM IISummary page 4…: Class II Review Panel: Gastroenterology/Urology Product Code: PIF (Gastrointestinal tubes with enteral specific connectors) Predicate Device ICU Medical Lopez Valve K915171 Y MEDLINE , Medline Industries, Inc. Kl 9 1 759 Three Lakes Drive Page 2 of 8 Northfield, IL 60093 Reference… | 1992 |
| † | K160642 | Medline ENFit Syringe | 2016 |
| † | K082241 | The Dale Ace Connector (Access Controller for Enteral), Model H84104751 | 2008 |
| † | K151628 | Medline ENFit Connectors | 2015 |
| † | K150286 | Medline Enteral Feeding Sets | 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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K915171.
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 Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191759: Medline Quick Switch Valve with ENFit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191759
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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