510(k) · Cleared
ClearedRoss Enteral Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ross Products · FPD Tube, Feeding
Cleared on Jan 26, 1998 after a 210-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jan 26, 1998
- Review
- 210 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK972437 Ross Enteral Feeding TubeRoss Products · 1998
- Descendant · cites it directly · 4 of its ownK021991 Magnaflow Magnetically Guided Enteral Feeding TubeSyncro Medical Innovations, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK072787 Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model…Syncro Medical Innovations, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK110005 Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube-…Syncro Medical Innovations, Inc. · 2011
- Descendant · 4 generations on · 1 of its ownK160787 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube…Syncro Medical Innovations, Inc. · 2016
- Descendant · 5 generations on · 0 of its ownK191784 Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K021991Magnaflow Magnetically Guided Enteral Feeding TubeSyncro Medical Innovations, Inc. · 2002 · cites it directly4descendants
- K072787Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model GFT-111Syncro Medical Innovations, Inc. · 2007 · 2 generations on3descendants
- K110005Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR TubeSyncro Medical Innovations, Inc. · 2011 · 3 generations on2descendants
- K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel…Syncro Medical Innovations, Inc. · 2016 · 4 generations on1descendant
- K191784Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972437 | Ross Enteral Feeding Tube | Ross Products | 1998 | — |
| +1 | 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 | — |
| +3 | K110005 | Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR Tube | Syncro Medical Innovations, Inc. | 2011 | — |
| +4 | K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon… | Syncro Medical Innovations, Inc. | 2016 | — |
| +5 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPD? 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 FPD device
- #1 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021991 | Magnaflow Magnetically Guided Enteral Feeding Tube | 2002 | 4 |
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?
- Of its descendants, K021991 (Syncro Medical Innovations, Inc., 2002) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPD
118in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPD
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPD
10in 2025
MAUDE reports naming product code FPD, 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 | 1 | — | 0 | 19 |
| 2008 | 4 | 76 | 0 | 24 |
| 2009 | 4 | 69 | 0 | 40 |
| 2010 | 4 | 118 | 0 | 21 |
| 2011 | 2 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 38 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 1 | 55 |
| 2016 | 0 | — | 0 | 102 |
| 2017 | 0 | — | 0 | 34 |
| 2018 | 0 | — | 3 | 30 |
| 2019 | 1 | — | 1 | 19 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients…
Read the full statement (144 words)
The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel. The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972437 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972437: Ross Enteral Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972437
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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