510(k) · Decided
DecidedAquarius Extension Feeding Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degania Silicone, Ltd. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 28, 2014 as substantially equivalent to K132686 (Degania Silicone, Ltd., 2014) after a 40-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.
- Decided
- Jul 28, 2014
- Review
- 40 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132686 (2014). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK132686 Aquarius Low Profile Gastrostomy Feeding TubeDegania Silicone, Ltd. · 2014
- This deviceK141631 Aquarius Extension Feeding SetDegania Silicone, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK260110 danumed Extension Set for Gastrostomy ButtonDanumed Medizintechnik GmbH · 2026
- Descendant · cites it directly · 0 of its ownK250481 Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s. · 2025
- Descendant · cites it directly · 0 of its ownK192991 Vesco Medical Extension Feeding SetVesco Medical, LLC · 2020
Most influential descendants
Showing 3 of 3 · See all- K260110danumed Extension Set for Gastrostomy ButtonDanumed Medizintechnik GmbH · 2026 · cites it directly0descendants
- K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s. · 2025 · cites it directly0descendants
- K192991Vesco Medical Extension Feeding SetVesco Medical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132686 | Aquarius Low Profile Gastrostomy Feeding Tube | Degania Silicone, Ltd. | 2014 | — |
| 0 (this device) | K141631 | Aquarius Extension Feeding Set | Degania Silicone, Ltd. | 2014 | — |
| +1 | K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | 2026 | — |
| +1 | K250481 | Extension Feeding Set with ENFit™ Connectors | SKY Medical, a.s. | 2025 | — |
| +1 | K192991 | Vesco Medical Extension Feeding Set | Vesco Medical, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K132686 | Aquarius Low Profile Gastrostomy Feeding TubeSummary page 1…6.5980 e) Classification Name: Gastrointestinal tube and accessories f) Class: 11 g) Product code: MIT h) Unmodified/ Predicate device: 510(k) K132686 i) 51 0(k) submitterlholder: Degania Silicone Ltd j) FDA Registration Number: 8030107 k) Contact person: Zoya… | 2014 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K260110 (Danumed Medizintechnik GmbH, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141631: Aquarius Extension Feeding Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141631
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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