510(k) · Cleared
ClearedThe Dale Ace Connector (Access Controller for Enteral), Model H84104751
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dale Medical Products, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 30, 2008 as substantially equivalent to K915171 (Icu Medical, Inc., 1992) after an 84-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 30, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- KNT
- 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 deviceK082241 The Dale Ace Connector (Access Controller for Enteral), Model…Dale Medical Products, Inc. · 2008
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) | K082241 | The Dale Ace Connector (Access Controller for Enteral), Model H84104751 | Dale Medical Products, Inc. | 2008 | — |
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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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 1…n/Usual Name: GI tube connector Classification Name: Gastrointestinal tubes and accessories 3. PREDICATE DEVICES · Lopez Valve, K915171 4. DEVICE DESCRIPTION The Dale® ACE* Connector is a device that is inserted between the enteral tube and the fluid… | 1992 |
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 KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The Dale® ACE* Connector (*Access Controller for Enteral) is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines for up to 30 days. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082241: The Dale Ace Connector (Access Controller for Enteral), Model H84104751.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082241
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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