510(k) · Cleared
Recalled · Class II · 2024Mini ONE Enteral Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jan 29, 2015 as substantially equivalent to K971757 (Applied Medical Technologies, 1997) after a 105-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Jan 29, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- PIF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971757 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971757 Low Profile Feeding Set AccessoryApplied Medical Technologies · 1997
- This deviceK142989 Mini ONE Enteral Extension SetApplied Medical Technology, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971757 | Low Profile Feeding Set Accessory | Applied Medical Technologies | 1997 | — |
| 0 (this device) | K142989 | Mini ONE Enteral Extension Set | Applied Medical Technology, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K971757 | Low Profile Feeding Set AccessorySummary page 4…with Enteral Specific Connectors AMT Low Profile Feeding Set Accessory (Applied Medical Technology, Inc.) Predicate (cleared under K971757) Device: The Mini ONE® Enteral Extension Set is intended for use with compatible enteral Intended Use:… | 1997 |
| † | K110804 | Amt G-J Tube | 2011 |
| † | K123716 | Amt Low-Profile Transgastric-Jejunal Feeding Tube Kit | 2013 |
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 |
|---|---|---|---|---|
| Nov 26, 2024 | Class II | Z-0819-2025 | Under Investigation by firm | The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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. 2015, 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 Mini ONE® Enteral Extension Set is intended for use as an extension set for the Mini ONE® Gastrostomy Button, G-Jet Gastrojejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible enteral feeding devices. The extension set is for administering feeding, medications, and decompression to compatible devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142989 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142989: Mini ONE Enteral Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142989
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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