510(k) · Decided
DecidedGabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syncro Medical Innovations, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Aug 9, 2016 as substantially equivalent to K110005 (Syncro Medical Innovations, Inc., 2011) after a 140-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Aug 9, 2016
- Review
- 140 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972437 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK972437 Ross Enteral Feeding TubeRoss Products · 1998
- 3 generations backK021991 Magnaflow Magnetically Guided Enteral Feeding TubeSyncro Medical Innovations, Inc. · 2002
- 2 generations backK072787 Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model…Syncro Medical Innovations, Inc. · 2007
- 1 generation backK110005 Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube-…Syncro Medical Innovations, Inc. · 2011
- This deviceK160787 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube…Syncro Medical Innovations, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK191784 Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191784Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972437 | Ross Enteral Feeding Tube | Ross Products | 1998 | — |
| −3 | K021991 | Magnaflow Magnetically Guided Enteral Feeding Tube | Syncro Medical Innovations, Inc. | 2002 | — |
| −2 | K072787 | Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model GFT-111 | Syncro Medical Innovations, Inc. | 2007 | — |
| −1 | K110005 | Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR Tube | Syncro Medical Innovations, Inc. | 2011 | — |
| 0 (this device) | K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon… | Syncro Medical Innovations, Inc. | 2016 | — |
| +1 | K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | 2019 | — |
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 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 |
|---|---|---|---|
| * | K110005 | Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR TubeSummary page 6…f 3 A.6 Legally Marketed Device To Which The Device Is Substantially Equivalent Predicate Device Syncro Blue Tube Magnetically Guided Enteral Feeding Tube (K110005) Reference Device Rusch Miller-Abbott Tube (K010797). A.7 Description Of The Device The Gabriel Feeding Tube with Balloon se… | 2011 |
| † | K010797 | Rusch Miller-Abbott Tube | 2002 |
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 |
|---|---|---|---|
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | 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 18 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191784 (Syncro Medical Innovations, Inc., 2019) 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. 2016, 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 Gabriel Feeding Tube with balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.
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/K160787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160787: Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160787
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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