510(k) · Decided
DecidedGabriel Feeding Tube with Balloon, and EnFit Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syncro Medical Innovations, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Nov 15, 2019 as substantially equivalent to K160787 (Syncro Medical Innovations, Inc., 2016) after a 135-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Nov 15, 2019
- Review
- 135 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972437 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK972437 Ross Enteral Feeding TubeRoss Products · 1998
- 4 generations backK021991 Magnaflow Magnetically Guided Enteral Feeding TubeSyncro Medical Innovations, Inc. · 2002
- 3 generations backK072787 Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model…Syncro Medical Innovations, Inc. · 2007
- 2 generations backK110005 Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube-…Syncro Medical Innovations, Inc. · 2011
- 1 generation backK160787 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube…Syncro Medical Innovations, Inc. · 2016
- This deviceK191784 Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972437 | Ross Enteral Feeding Tube | Ross Products | 1998 | — |
| −4 | K021991 | Magnaflow Magnetically Guided Enteral Feeding Tube | Syncro Medical Innovations, Inc. | 2002 | — |
| −3 | 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 | — |
| −1 | K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon… | Syncro Medical Innovations, Inc. | 2016 | — |
| 0 (this device) | K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | 2019 | — |
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? (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 |
|---|---|---|---|
| * | K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel…Summary page 5…PIF 5.3 Equivalence Claimed to Predicate Device The Gabriel® Feeding Tube with Balloon, and EnFit Connector is equivalent to the Gabriel® Feeding Tube with Balloon (K160787), manufactured by SYNCRO MEDICAL INNOVATIONS, INC.… | 2016 |
| † | K915171 | Lopez Valve TM II | 1992 |
| † | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | 1994 |
| † | K181981 | CO2 Sampling Line | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
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. 2019, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K191784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191784: Gabriel Feeding Tube with Balloon, and EnFit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191784
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