510(k) · Cleared
ClearedMagnaflow Magnetically Guided Enteral Feeding Tube
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 Jul 18, 2002 as substantially equivalent to K972437 (Ross Products, 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Jul 18, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972437 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972437 Ross Enteral Feeding TubeRoss Products · 1998
- This deviceK021991 Magnaflow Magnetically Guided Enteral Feeding TubeSyncro Medical Innovations, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK072787 Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model…Syncro Medical Innovations, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK110005 Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube-…Syncro Medical Innovations, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK160787 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube…Syncro Medical Innovations, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK191784 Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K072787Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model GFT-111Syncro Medical Innovations, Inc. · 2007 · cites it directly3descendants
- K110005Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR TubeSyncro Medical Innovations, Inc. · 2011 · 2 generations on2descendants
- K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel…Syncro Medical Innovations, Inc. · 2016 · 3 generations on1descendant
- K191784Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972437 | Ross Enteral Feeding Tube | Ross Products | 1998 | — |
| 0 (this device) | K021991 | Magnaflow Magnetically Guided Enteral Feeding Tube | Syncro Medical Innovations, Inc. | 2002 | — |
| +1 | K072787 | Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model GFT-111 | Syncro Medical Innovations, Inc. | 2007 | — |
| +2 | K110005 | Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR Tube | Syncro Medical Innovations, Inc. | 2011 | — |
| +3 | K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon… | Syncro Medical Innovations, Inc. | 2016 | — |
| +4 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K972437 | Ross Enteral Feeding TubeSummary page 1…ed Enteral Feeding Tube Device common name: Enteral Feeding Tube Device classification Tube, Feeding at CFR 21 876.5980 name: Legally marketed devices K972437: Flexiflo Magnetically Guided Enteral Feeding Tube to which the device is substantially equivalent: Description of device:… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072787 | Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model GFT-111 | 2007 | 3 |
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, K072787 (Syncro Medical Innovations, Inc., 2007) has gone furthest, with 3 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.
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 MagndFlowB Magnetically Guided Enteral Feeding 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, bum 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021991: Magnaflow Magnetically Guided 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/K021991
Report an extraction error
Are you the manufacturer?
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