510(k) · Cleared
ClearedGientriport with Universal Single Lumen Adaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Cleared on Jan 6, 2006 as substantially equivalent to K040388 (Kendall, 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 6, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- FEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945964 (1995). 7 ancestors in all, the oldest K915171 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK945964 Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSherwood Medical Co. · 1995
- 1 generation backK040196 Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsTyco Healthcare/Kendall · 2004 · Recalled
- This deviceK053410 Gientriport with Universal Single Lumen AdaptorKendall · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets | Sherwood Medical Co. | 1995 | — |
| −1 | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets | Tyco Healthcare/Kendall | 2004 | 5 |
| 0 (this device) | K053410 | Gientriport with Universal Single Lumen Adaptor | Kendall | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 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 FEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040388 | Next Generation Salem SumpSummary page 1…on Classification Panel: Gastroenterology Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Kendall Next Generation Salem Sump, 510(k) number K040388, cleared on May 1 7 th, 2004. * Kendall E-Pump Enteral Feeding Sets, 510(k) number K040196, cleared on May 5 th, 2004… | 2004 |
| * | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsSummary page 1…uivalence Is Claimed: * Kendall Next Generation Salem Sump, 510(k) number K040388, cleared on May 1 7 th, 2004. * Kendall E-Pump Enteral Feeding Sets, 510(k) number K040196, cleared on May 5 th, 2004 (Division Sign-Off) Division of Reproductive, Abdominal,… | 2004 |
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 11 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K040388.
How does its category compare?
All FEG devicesFEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEG
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FEG
Too few FEG 510(k)s in any year since 2007 to give a median.
Recalls per year · FEG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEG
46in 2025
MAUDE reports naming product code FEG, 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 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 36 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 10 | 33 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 2 | 46 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is intended for gastric decompression and delivery of fluids, including irrigation,
nutritional supplements, and medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053410: Gientriport with Universal Single Lumen Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053410
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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