510(k) · Cleared
ClearedAquarius Nasal Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degania Silicone, Ltd. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Oct 16, 2014 as substantially equivalent to K112511 (Covidien Lp, Formerly Registered AS Kendall, 2012) and 1 other predicate after a 108-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Oct 16, 2014
- Review
- 108 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913407 (1992). 5 ancestors in all, the oldest K831868 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK913407 Nasojejunal Feeding Tube W/Gastric DrainageSandoz Nutrition · 1992
- 1 generation backK961664 Compat Nasojejunal Feeding TubeSandoz Nutrition · 1996
- This deviceK141753 Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK181787 Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019
Most influential descendants
Showing 1 of 1 · See all- K181787Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913407 | Nasojejunal Feeding Tube W/Gastric Drainage | Sandoz Nutrition | 1992 | — |
| −1 | K961664 | Compat Nasojejunal Feeding Tube | Sandoz Nutrition | 1996 | — |
| 0 (this device) | K141753 | Aquarius Nasal Feeding Tube | Degania Silicone, Ltd. | 2014 | — |
| +1 | K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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? (2)
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 |
|---|---|---|---|
| * | K112511 | Dobbhoff Dual Port Feeding TubeSummary page 5…egania Silicone Itd, Tel: 46726755122, e-mail: [email protected] c) ldentification of Legally Marketed devices: e DOBBHOFF ™ Dual Port Feeding Tube, cleared under 510(k) K112511 o COMPAT Nasojejunal feeding tube, cleared under K961664 d) Device Brief Description The Aquarius™ Nasal Tube / Nasogastric Tub… | 2012 |
| * | K961664 | Compat Nasojejunal Feeding TubeSummary page 5…l.com c) ldentification of Legally Marketed devices: e DOBBHOFF ™ Dual Port Feeding Tube, cleared under 510(k) K112511 o COMPAT Nasojejunal feeding tube, cleared under K961664 d) Device Brief Description The Aquarius™ Nasal Tube / Nasogastric Tube (NG-Tube) & Nasojejunal Tube (NJ Tube) / are enteral fe… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | 2019 | 0 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 18.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K181787 (Cedic S.R.L., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112511.
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. 2014, 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 Aquarius™ Nasogastric Tubes arc for the administration of nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Nasogastric feeding tube is designated for patients who require intermittent or continues feeding/and or medication into the stomach. The Aquarius™ Nasojejunal Feeding Tubes are for the administration of…
Read the full statement (115 words)
The Aquarius™ Nasogastric Tubes arc for the administration of nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Nasogastric feeding tube is designated for patients who require intermittent or continues feeding/and or medication into the stomach.
The Aquarius™ Nasojejunal Feeding Tubes are for the administration of nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutricnts through normal mastication and deglutition. Designated for patients who are critically ill and require early enteral feeding/and or medication into the small intestine; may be with a dual tube allowing simultancous gastric drainage.
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/K141753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141753: Aquarius Nasal Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141753
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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